Search results from the Australian New Zealand Clinical Trials Registry

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Broad Health Condition: Cancer
Specific Condition: Myeloma
Recruitment Status: Recruiting

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Improving national immunoglobulin stewardship and clinical outcomes for patients with myeloma

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Trial Information

Trial summary

This study will investigate the real-world use of immunoglobulin therapy on clinical outcomes for patients with myeloma using the Australian and New Zealand Myeloma and Related Diseases Registry. Patients with the blood cancer myeloma are at risk of serious infection because of low levels of protective antibodies due to their condition and its treatment. Immunoglobulin therapy (made from plasma) is used to replace missing antibodies to prevent or treat infections in patients with blood cancers. 

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have been diagnosed with multiple myeloma and participated in the Myeloma and Related Diseases Registry 

Study details
This observational study will collect ‘real world’, up-to date Australian clinical and laboratory information on immunoglobulin use. Information on participants’ disease, progression, infections and immunoglobulin use will be documented in the registry at fixed time points after diagnosis.

The results of this study will be important to provide better care for patients with myeloma and other blood cancers and to improve stewardship of the national blood supply. The study will also provide a new and lower cost framework for conducting future large clinical trials of immunoglobulin therapy in Australia in myeloma and in other similar conditions.

Broad Health ConditionMultiple myeloma

Specific Health ConditionCancer
Myeloma

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,WA,VIC

Hospital
The Alfred - Melbourne

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Canberra Hospital - Garran

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
St Vincent's Private Hospital - Fitzroy

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Nepean Hospital - Kingswood

Hospital
The Northern Hospital - Epping

Hospital
Royal North Shore Hospital - St Leonards

Postcode
3004 - Melbourne

Postcode
2605 - Garran

Postcode
6009 - Nedlands

Postcode
3065 - Fitzroy

Postcode
4102 - Woolloongabba

Postcode
2747 - Kingswood

Postcode
3076 - Epping

Postcode
2065 - St Leonards

Anticipated date of last participant enrolment31/12/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Newly diagnosed with multiple myeloma
A participant in the MRDR Registry

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients who decline to participate
Patients who do not have a diagnosis of multiple myeloma
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Monash University
Primary Sponsor Address: 553 St Kilda Road Melbourne VIC 3004
Primary Sponsor Country: Australia

Trial IDACTRN12619001248156

Contact person for information and recruitmentDr
Laura Sellick
Public Health and Preventive Medicine Monash University 553 St Kilda rd, Melbourne VIC, 3004
+61 3 99030251

Further information iconsphpm.improve@monash.edu
Australia

Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study

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Trial Information

Trial summary

The primary purpose of this trial is to assess appropriate treatment approach newly diagnosed with multiple myeloma with respect to frailty assessment . 

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are a candidate for chemotherapy but not for autologous stem cell transplant.

Study details
Eligible participants will be treated with their allocated treatment regimen (bortezomib or lenalidomide) through randmonisation. All patients will continue on treatment until the either the development of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.
It is hoped that the findings of this trial will establish the most appropriate treatment approach in the context of the Australian re-imbursement environment. 

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,TAS,WA,VIC

Hospital
The Alfred - Melbourne

Hospital
St George Hospital - Kogarah

Hospital
Calvary Mater Newcastle - Waratah

Postcode
3004 - Melbourne

Postcode
2217 - Kogarah

Postcode
2298 - Waratah

Anticipated date of first participant enrolment15/11/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male and Female patients, equal to or greater 18 years of age.

2.	Symptomatic NDMM as per IMWG criteria

3.	Measurable disease as defined by a paraprotein 5g/L and/or an involved light chain isotype 100mg/l with an abnormal kappa:lambda ratio.

4.	Not eligible for high-dose melphalan conditioned autologous stem cell transplantation (ASCT) due to age and/or co-morbidities.

5.	No contraindication to the use of any of the study drugs.

6.	Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.

7.	Adequate haematological parameters - Hb equal to or greater 80g/L (RBC transfusions as per institutional protocol are allowed); absolute neutrophil count equal to or greater 1.0 x 109/L; and, platelet count equal to or greater 50 x 109/L (equal to or greater 30 x 109/L if MM involvement in the marrow is greater than 50%) without platelet transfusion within 7 days of the screening platelet count.

8.	Has provided written informed consent.

9.	Women of childbearing potential must have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/mL performed before, during and after treatment. 

10.	Women of childbearing potential and male subjects who are sexually active with WOCP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Prior treatment for MM apart from localised radiotherapy and/or a short course of steroids (dexamethasone 160mg or equivalent) for emergency management of MM related symptoms.

2.	Patients who have had myocardial infarction within 3 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

3.	Creatinine clearance <30ml/min that persists after correction of recognisable reversible factors e.g. hypercalcaemia, dehydration, sepsis etc.

4.	Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.

5.	Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency (HIV) positivity.

6.	Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.

7.	Patient (to whom it is relevant) who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention program.

8.	Active malignancy with the exception of any of the following: 
a.	Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
b.	Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
c.	Stage 1 prostate cancer that does not require treatment.
d.	Any other cancer from which the subject has been disease-free for > 2 years.

9.	Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Leukaemia & Lymphoma Group
Primary Sponsor Address: 35 Elizabeth St, Richmond VIC 3121
Primary Sponsor Country: Australia

Trial IDACTRN12619001199101

Contact person for information and recruitmentMiss
Flora Yuen
Alfred Hospital 55 Commercial Road Melbourne VIC 3004
+61 3 9076 5407

Further information iconflora.yuen@alfred.org.au
Australia

Stem cell transplant influenza vaccination strategies

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Trial Information

Trial summary

This study will compare the level of protection afforded by two different influenza vaccination strategies in patients who have undergone autologous haematopoietic stem cell transplantation. 

Who is it for?
You may be eligible to join this study if you are aged at least 18 years, have received an autologous haematopoietic stem cell transplantation (autoHSCT) within the last 12 months, and have not received an influenza vaccine for the 2019 season following your transplant.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive a new two dose strategy, which consists of the trivalent high dose influenza vaccine followed by a second dose of quadrivalent standard dose influenza vaccine one month later. Participants in the other group will receive the current standard two dose strategy of quadrivalent influenza vaccine one month apart. All vaccines will be administered by injection into the muscle.

All participants will be required to provide blood samples at four time points: 1) before first influenza vaccination, 2) before second influenza vaccination; 3) 21-28 days post-second-vaccination; and 4) approximately 6 months post-vaccination. They will also be asked to provide information on vaccination history, side effects and occurrence of influenza-like illnesses (ILI). Participants who develop respiratory symptoms during the study period will be asked to provide a nasal swab. 

Findings may assist in improving vaccine responses and protection from influenza in a highly vulnerable patient group

Broad Health Conditionautologous haematopoietic stem cell transplantation (autoHSCT)
influenza
myeloma
lymphoma

Specific Health ConditionCancer
Myeloma
Infection
Other infectious diseases
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Postcode
3000 - Melbourne

Anticipated date of first participant enrolment1/05/2019

Anticipated date of last participant enrolment1/10/2019

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Patients aged greater than or equal to 18 years and have received autoHSCT within last 12 months.
2.	Willing and able to provide a blood sample just prior to vaccination, 21-28 days post dose (2 doses) and roughly 6 months post-vaccination.
3.	Has not received influenza vaccine for the 2019 season following transplantation
4.	No known contraindications for influenza vaccination.
5.	Not recently (within last 7 days) or currently ill, or has a fever above 38°C.
6.	Willing to provide current mobile phone number for SMS reminders

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Known contraindication(s) for TIV (e.g. hypersensitivity to vaccine component (including eggs)).
2.	Recent immunosuppressive treatment with anti-CD20 antibody, Bruton’s tyrosine kinase inhibitor (within last 6 months)
3.	Recently or currently ill, or has a fever above 38°C
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCullum Cancer Institute
Primary Sponsor Address: 305 Grattan Street, Melbourne VIC 3000
Primary Sponsor Country: Australia

Trial IDACTRN12619000617167

UTNU1111-1231-5881

Contact person for information and recruitmentMs
Sharon Carvalho
Peter MacCullum Cancer Centre 305 Grattan Street Melbourne VIC 3000
+61 3 85597994

Further information iconsharon.carvalho@petermac.org
Australia

Effects of Exercise on Health Outcomes in Multiple Myeloma

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Trial Information

Trial summary

This study will evaluate the effect of exercise on health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours in people with multiple myeloma.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of multiple myeloma, and are free of any conditions that may prevent safe completion of the exercise demands of the study.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will immediately commence a 3 stage exercise program. The first stage will be gym-based and involves 2 x supervised sessions and 1 home-based session per week for 12 weeks. All supervised classes will be delivered by an Accredited Exercise Physiologist. Stage 2 is a 12 week home-based program (3 sessions/week) with weekly telephone support, with the option to attend one group-based class each week delivered by an Accredited Exercsie Physiologist. Stage 3 involves a maintenance home-based program for a further 6 months. The program will be individualised to the participants’ cardiorespiratory fitness and bone lesions, and will involve high-intensity aerobic exercise, resistance training and impact loading. Participants in the other group will receive the same program after a 12 week wait, during which time they will receive usual care.

All participants will undergo a number of assessments at baseline, 12 weeks, 24 weeks, 36 weeks (group 2 only) 12 months (group 1 only) and 15 months (group 2 only) in order to evaluate health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours.
The potential findings of this proposed research will ultimately influence the inclusion of exercise as part of standard care to improve the health and longevity of people with multiple myeloma.

Broad Health ConditionMultiple myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Greenslopes Private Hospital - Greenslopes

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4120 - Greenslopes

Postcode
4102 - Woolloongabba

Postcode
4029 - Herston

Anticipated date of first participant enrolment18/03/2019

Anticipated date of last participant enrolment31/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Diagnosis of multiple myeloma
- Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
- Cognitively capable of consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- Abnormal resting electrocardiogram
- Unstable angina
- Cognitive impairment that impedes the ability to complete questionnaires
- Any intellectual or physical disability which would make exercise intervention participation  unsafe for the individual 
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Tina Skinner
Primary Sponsor Address: Senior Lecturer in Exercise Physiology School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia QLD 4072
Primary Sponsor Country: Australia

Trial IDACTRN12619000387123

Contact person for information and recruitmentMrs
Jennifer Nicol
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road The University of Queensland St Lucia QLD 4072
+61 409769373

Further information iconj.nicol@uq.edu.au
Australia

A prospective Phase II study of Isatuximab Rescue for Inadequate response to Lenalidomide and Dexamethasone in transplant ineligible patients with newly diagnosed multiple myeloma

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Trial Information

Trial summary

The purpose of this study is to determine whether Isatuximab (a new drug), when combined with chemotherapy, improves response to treatment. 

Who is it for?

You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant.

Study Details
Eligible participants will receive lenalidomide and dexamethasone (Ld). Participants who have inadequate response to upfront treatment with Ld, will have the addition of Isatuximab. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. 
Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.
It is hoped that the findings of this trial will establish the benefits of Isatuximab in combination with Ld for the treatment of multiple myeloma patients early in the course of their disease. 

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA,TAS,VIC

Hospital
The Alfred - Prahran

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
Epworth Freemasons (Clarendon Street) - East Melbourne

Hospital
Royal Hobart Hospital - Hobart

Hospital
Flinders Medical Centre - Bedford Park

Postcode
3004 - Prahran

Postcode
3065 - Fitzroy

Postcode
3002 - East Melbourne

Postcode
7000 - Hobart

Postcode
5042 - Bedford Park

Anticipated date of first participant enrolment25/03/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Patient has voluntarily agreed and has given written informed consent to both the main study and the correlative study.
2. Male and Female patients, 18 years or older of age
3. Diagnosed with MM (diagnosis of MM as per IMWG)
4. Measurable M-component in serum or urine, In patients with no detectable M-component, an abnormal FLC ratio on the serum FLC assay
5. No prior therapies (except radiotherapy or short
course of corticosteroids equivalent to dexamethasone 160mg in the last 28 days) or have
started Ld as first line therapy but not completed cycle 4 of Ld and whose response status is SD or better
6. ECOG performance status 0-2 
7. Adequate liver function (ALT, AST and GGT less than or equal to 2.5 x institutional upper limit of normal; GGT less than or equal to'1.5 x institutional upper limit of normal )
8. CrCl >15ml/min
9. Hb greater than or equal to 80g/L, Platelet count greater than or equal to 75 x 10^9/L, absolute neutrophil count greater than or equal to 1.0 x 10^9/L
10. No contraindication to the use of any of the study drugs
11. Life expectancy of greater than 6 months
12. Patients must be registered on and abide by the Celgene i-access Risk Management Program before receiving first dose of lenalidomide (www.iaccesscelgene.com)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Primary amyloidosis
2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
requirements
3.Pregnant or lactating women.
4. Known acquired immunodeficiency syndrome (AIDS-related illness) or known HIV disease requiring antiviral treatment, or active hepatitis A, B, or C infection
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Myeloma Research Consortium
Primary Sponsor Address: 55 Commercial Rd, Melbourne VIC 3004
Primary Sponsor Country: Australia

Trial IDACTRN12619000362190

Contact person for information and recruitmentMiss
Flora Yuen
Alfred Hospital 55 Commercial Road, Melbourne VIC 3004
+61390765407

Further information iconflora.yuen@alfred.org.au
Australia

Can a 5-Session Cognitive Behaviour Therapy Intervention Improve Emotional Distress and Quality of Life for Allogeneic Hematopoietic Stem Cell Transplant Survivors?

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Trial Information

Trial summary

The purpose of this study is to see if a 5 session psychological therapy program delivered after bone marrow transplantation can have a positive impact on quality of life and psychological distress  in these patients.

Who is it for?
You may be eligible for this study if you are aged 18 or older and have received a bone marrow transplant in the last 3 to 12 months.

Study details
All participants in this study will receive 5 individual sessions of face-to-face cognitive behavioural therapy targeting mental adjustment and coping strategies. Participants will also need to do approximately 10 minutes of ‘homework’ every day following each of the first 4 sessions. As part of the study, participants will complete questionnaires about their quality of life, psychological distress, mental adjustment, coping and self-efficacy before and after the 5 session intervention. Participants will also be asked to complete questionnaires about their psychological distress and homework completion at each session. 

It is hoped this research will provide evidence this program improves mental health outcomes in this patient population.

Broad Health ConditionQuality of Life in Allogeneic Bone Marrow Transplant Recipients

Specific Health ConditionCancer
Leukaemia - Chronic leukaemia
Cancer
Leukaemia - Acute leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Hodgkin's
Cancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
The Alfred - Prahran

Hospital
Peter MacCallum Cancer Centre - Melbourne

Postcode
3004 - Prahran

Postcode
3000 - Melbourne

Anticipated date of first participant enrolment16/12/2019

Anticipated date of last participant enrolment12/10/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Participants will be allogeneic HSCT recipients who are English speaking, over 18 years of age, and who are 3-12 months post-transplantation.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Experiencing a delirium, currently receiving psychotherapeutic treatment or unable to individually provide full informed consent (due to intellectual disability, acute medical illness etc).
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Peter Norton
Primary Sponsor Address: School of Psychological Sciences Level 6, 18 Innovation Walk, Monash University, Wellington Road, Clayton, Victoria, 3168
Primary Sponsor Country: Australia

Trial IDACTRN12618001663246

Contact person for information and recruitmentMr
Richard Lawrence
Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Road, Melbourne VIC 3004
+61 437070494

Further information iconrichard.lawrence@monash.edu
Australia

Daratumumab-lenalidomide-dexamethasone (DRd) salvage for newly diagnosed Multiple Myeloma patients who fail bortezomib induction therapy

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Trial Information

Trial summary

The purpose of this study is to assess whether a new combination of therapies, with stem cell transplant, will prolong remission and hold off recurrence of myeloma in patients who have been diagnosed with multiple myeloma and have not responded to standard treatment (currently Bortezomib). 

Who is it for?

You may be eligible for this study if you are an adult who has been diagnosed with multiple myeloma and have had a minimal or no response to bortezomib based induction therapy.

Study details

If participants consent to take part in this study, they will receive the following:
- Four cycles of daratumumab, lenalidomide and dexamethasone. These medications will be used to alter the immune system response to myeloma cells. 
- A transplant of their own, non-cancerous cells. 
- This will be followed 12 cycles of the same medications given initially (daratumumab, lenalidomide and dexamethasone) to ‘consolidate’ treatment. 
- After the completion of the 12 cycles, all participant will commence ‘maintenance’ phase of this study while involves daily doses of lenalidomide.

Patients will also undergo routine blood assessments as per standard of care

It is hoped that this treatment will provide an alternative treatment to those who have been diagnosed with multiple myeloma and have not responded to standard treatment. 

Broad Health ConditionNewly-diagnosed multiple myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,WA,VIC

Anticipated date of first participant enrolment1/03/2019

Anticipated date of last participant enrolment1/09/2020

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male and Female patients, greater than or equal to 18 years of age.
2.	Symptomatic NDMM as per IMWG criteria 
3.	Eligible for high-dose melphalan conditioned ASCT.
4.	Patients who have had a sub-optimal response to a bortezomib-based induction therapy, where a sub-optimal response is defined as:
The failure to achieve at least a minimal response (MR) with a minimum of 2 cycles of a prior bortezomib-based induction therapy OR a partial response (PR) with 4 cycles of a prior bortezomib-based induction therapy
OR are bortezomib refractory, that is, have progressed while on bortezomib therapy or within 60 days of receiving their last dose of bortezomib. 
5.	No contraindication to the use of any of the study drugs.
6.	Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.
7.	Absolute neutrophil count greater than or equal to 1.0 x 109/L.
8.	Platelet count greater than or equal to 50 x 109/L (greater than or equal to 30 x 109/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
9.	Hb greater than or equal to 80g/L, red cell transfusions as per institutional protocol are allowed.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Patients who have had myocardial infarction within 6 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
2.	Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.
3.	Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency (HIV) positivity.
4.	Subject has significant airways disease according to the following definitions:
a.	Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal. 
b.	Subject has had known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
5.	Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
6.	Any patient who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention program.
7.	Active malignancy with the exception of any of the following: 
a.	Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
b.	Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for greater than 2 years.
c.	Stage 1 prostate cancer that does not require treatment.
d.	Any other cancer from which the subject has been disease-free for greater than 2 years.
8.	Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
9.	Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australiasian Leukaemia and Lymphoma Group
Primary Sponsor Address: 35 Elizabeth St Richmond VIC 3121
Primary Sponsor Country: Australia

Trial IDACTRN12618001490268

Contact person for information and recruitmentProf
Andrew Spencer
Australian Centre For Blood Diseases 99 Commercial Road Melbourne VIC 3004
+61 3 990 30122

Further information iconaspencer@netspace.com
Australia

A trial of Venetoclax in combination with Bortezomib-Cyclophosphamide-Dexamethasone (VCD) as induction therapy for newly diagnosed myeloma patients

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Trial Information

Trial summary

The primary purpose of this trial is to assess whether the addition of venetoclax to a velcade (bortezomib), cyclophosphamide and dexamethasone treatment regime will cause an improvement in disease progression free survival.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are a candidate for chemotherapy and autologous stem cell transplant.

Study details
Eligible participants will be treated with 4 35 day cycles of venetoclax, velcade, cyclophosphamide and dexamethasone (V-VCD) followed by a high-dose melphalan conditioned autologous stem cell transplant (ASCT) with residual disease evaluation at day 100 post-ASCT.  Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.
It is hoped that the findings of this trial will establish the benefits of venetoclax in combination with VCD for the treatment of multiple myeloma patients early in the course of their disease. 

Broad Health Conditionmultiple myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD,TAS,VIC

Hospital
The Alfred - Prahran

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
St George Hospital (QLD) - St George

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Royal Hobart Hospital - Hobart

Postcode
3004 - Prahran

Postcode
3084 - Heidelberg

Postcode
4487 - St George

Postcode
3168 - Clayton

Postcode
3000 - Melbourne

Postcode
7000 - Hobart

Anticipated date of first participant enrolment1/09/2018

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.Male or female patients aged 18 years or older.
2.Patient has newly diagnosed treatment naïve MM as per the IMWG criteria and is planned to proceed to high-dose chemotherapy conditioned ASCT as part of first-line treatment.
3.Treatment naïve apart from a limited exposure to corticosteroids and/or radiotherapy for urgent symptom control.
4.No contraindication to the use of any of the study drugs.
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
6.Subject has measurable disease at screening, defined as at least one of the following:
- Serum M-protein >= 5 g/L, OR
- Urine M-protein >= 200 mg in 24-hours, OR
- Serum immunoglobulin free light chain (FLC) >= 100 mg/L provided serum FLC ratio abnormal.
7.Subject must meet the following laboratory parameters, per laboratory reference range:
- Absolute neutrophil count (ANC) >= 1 x 10^9/L within 2 weeks prior to starting induction. Subjects may use growth factor support to achieve ANC eligibility criteria.
- Platelet count >= 50 x 109/L, within 2 weeks prior to starting induction. For subjects with > 50% myeloma involvement in the bone marrow, a platelet count of >= 30 x10^9/L within 2 weeks prior to starting induction is allowed. Subjects cannot receive a platelet transfusion within 72 hours prior to the platelet count used for eligibility.
- Haemoglobin >= 80 g/L, within 2 weeks prior to starting induction. Subjects may receive RBC transfusions in accordance with institutional guidelines to meet this criterion.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <= 3 × upper limit of normal range (ULN).
- Total bilirubin <= 1.5 x ULN (unless bilirubin rise is due to Gilbert syndrome or of non-hepatic origin).
- CrCl >= 30 mL/minute (min), measured by 24-hour urine collection or calculated using Cockcroft-Gault formula:
CrCl = ((140 – age in years) × weight in kg × 0.85 if female) / (72 × serum creatinine in mg/dL)
8.Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC) prior to the initiation of any screening or study-specific procedures.
9.If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation at least 3 months before study participation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and 90 days after last dose of study drug.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.Subject has any of the following conditions:
- Non-secretory or oligo-secretory MM.
- Active plasma cell leukemia i.e., either 20% of peripheral white blood cells comprised of plasma cells or > 2.0 × 109/L) circulating plasma cells by standard differential.
- Waldenström's macroglobulinemia.
- Amyloidosis.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Subject is known to be positive for Human Immunodeficiency Virus (HIV)
- Significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of induction, or congestive heart failure New York Heart Association (NYHA) Class >= 3.
- Major surgery within 4 weeks prior to starting induction.
- Uncontrolled and/or active systemic infections (viral, bacterial or fungal).
- Chronic hepatitis B (HBV) or hepatitis C (HCV) requiring treatment.
- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to starting induction.
- Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to starting induction.
- Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study.
2.Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions:
- Adequately treated in situ carcinoma of the cervix uteri or the breast
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
- Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment
- Previous malignancy with no evidence of disease, confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study
3.Subject has a hypersensitivity or allergy to any of the components of study therapy including Venetoclax, Bortezomib, boron, mannitol, or Dexamethasone.
4.Subject has received any prior anti-MM with the exception of Dexamethasone (total dose not exceeding 160mg) or localized radiotherapy for the emergency management of newly diagnosed MM.
5.Subject has received a strong or moderate CYP3A inhibitor or inducer within 1 week prior to commencing study treatment.
6.Administration or consumption of grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville orange) or star fruit within 3 days prior to the first dose of study drug.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Alfred Health
Primary Sponsor Address: Alfred Hospital, 55 Commercial Road, Melbourne, VIC, 3004
Primary Sponsor Country: Australia

Trial IDACTRN12618001085268

UTNU1111-1216-0528

Contact person for information and recruitmentMs
Flora Yuen
Alfred Health, 55 Commercial Road, Melbourne, Victoria, 3004
+61 3 90765407
+61 3 90765531
Further information iconF.Yuen2@alfred.org.au
Australia

Myeloma and Related Diseases Registry

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Trial Information

Trial summary

This observational study is collecting information from patients to form the Myeloma and Related Diseases Registry (MRDR)

Who is it for?
You may be eligible for this study if you have a diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of undetermined significance (MGUS).

Study details
Medical information including diagnostic tests, therapy and demographics will be provided by medical records. Participants can also provide information regarding their quality of life using a questionnaire.

It is hoped this registry will enable clinicians and hospitals to provide the best possible care to people with the included conditions and allow the evaluations of new therapies.

Broad Health ConditionMultiple Myeloma
Plasmacytoma
Plasma cell leukaemia
Monoclonal gammopathy of undetermined significance (MGUS)

Specific Health ConditionCancer
Myeloma
Blood
Other blood disorders
Inflammatory and Immune System
Other inflammatory or immune system disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Alfred - Prahran

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Prince Alfred Hospital - Camperdown

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
The Northern Hospital - Epping

Hospital
St George Hospital - Kogarah

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Cabrini Hospital - Malvern - Malvern

Hospital
The Canberra Hospital - Garran

Hospital
Box Hill Hospital - Box Hill

Hospital
Royal Hobart Hospital - Hobart

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Latrobe Regional Hospital - Traralgon

Hospital
Concord Repatriation Hospital - Concord

Hospital
Icon Cancer Care South Brisbane - South Brisbane

Hospital
Icon Cancer Care Chermside - Chermside

Hospital
Icon Cancer Care Southport - Southport

Hospital
Icon Cancer Care Wesley - Auchenflower

Hospital
Epworth Freemasons - Melbourne

Hospital
Hollywood Private Hospital - Nedlands

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Lismore Base Hospital - Lismore

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
Frankston Hospital - Frankston

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
Liverpool Hospital - Liverpool

Hospital
Sunshine Hospital - St Albans

Hospital
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park

Hospital
Royal North Shore Hospital - St Leonards

Postcode
3004 - Prahran

Postcode
3084 - Heidelberg

Postcode
4102 - Woolloongabba

Postcode
2050 - Camperdown

Postcode
6009 - Nedlands

Postcode
3076 - Epping

Postcode
2217 - Kogarah

Postcode
3000 - Melbourne

Postcode
3168 - Clayton

Postcode
3144 - Malvern

Postcode
2605 - Garran

Postcode
3128 - Box Hill

Postcode
7000 - Hobart

Postcode
5042 - Bedford Park

Postcode
3844 - Traralgon

Postcode
2139 - Concord

Postcode
4101 - South Brisbane

Postcode
4032 - Chermside

Postcode
4215 - Southport

Postcode
4066 - Auchenflower

Postcode
3002 - Melbourne

Postcode
4029 - Herston

Postcode
2480 - Lismore

Postcode
3220 - Geelong

Postcode
3199 - Frankston

Postcode
3065 - Fitzroy

Postcode
2170 - Liverpool

Postcode
3021 - St Albans

Postcode
5037 - Kurralta Park

Postcode
2065 - St Leonards

Trial location outside Australia

Country
Korea, Republic Of

Country
Singapore

Country
Taiwan, Province Of China

Country
Hong Kong

Country
New Zealand

Country
Malaysia

Anticipated date of last participant enrolment31/12/2025

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients with a new diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of undetermined significance (MGUS). Diagnosis within 3 months prior to HREC approval at a site for myeloma, plasmacytoma, plasma cell leukaemia and within 5 years for MGUS in order to minimise retrospective data collection. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

People who decline to participate in the registry. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Monash University
Primary Sponsor Address: Wellington Road Clayton, Victoria, 3800
Primary Sponsor Country: Australia

Trial websitehttps://mrdr.net.au/

Trial IDACTRN12618000659202

Contact person for information and recruitmentDr
Elizabeth Moore
Attn: Myeloma and Related Diseases Registry Department of Epidemiology and Preventive Medicine School of Public Health and Preventive Medicine Monash University 553 St Kilda Road, Melbourne VIC 3004
+61 3 9903 0355

Further information iconsphpm-myeloma@monash.edu
Australia

Pilot study of 68Ga-Pentixafor positron emission tomography (PET) imaging in multiple myeloma

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Trial Information

Trial summary

This study aims to evaluate the performance of 68Ga-Pentixafor positron emission tomography (PET) imaging in a cohort of newly diagnosed and relapsed myeloma patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma.

Study details
All participants in this study will undergo pentixafor-PET imaging and simultaneous whole-body magnetic resonance imaging (MRI) in a single sitting. The PET scan is the investigational intervention while the MRI scan is the internal control/gold standard. A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan.  The scan involves lying flat with knees supported and arms resting above your head.  You will be scanned from head to mid thigh.  The scan time for the 68Ga-Pentixafor PET/MRI is approximately 1hour. After the examination is completed, you will be able to eat and drink normally.
Participants who have a positive PET will then be asked to undergo a second PET/MRI at the completion of their therapy. The scans will be interpreted using pre-specified criteria by investigators in the Department of Medical Imaging and Department of Nuclear Medicine at the Royal Brisbane Hospital.

We will be examining a) the accuracy of pentixafor-PET compared with whole-body MRI for diagnosing myeloma bone lesions, b) the relationship between PET positivity and conventional disease prognostic markers, and c) the correlation between PET response and conventional biochemical response markers. It is hoped that PET imaging may offer complementary information about disease staging and prognosis, as seen in many other cancers including lymphoma and melanoma.

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment8/05/2017

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Inclusion criteria
1. Age >18
2. Able to give informed consent
3. Newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria
1. Females of child-bearing potential
2. Males who are unwilling to use an effective contraceptive method
3. Uncontrolled pain which precludes patient from lying supine
4. Patient-reported claustrophobia or anxiety which, in the opinion of the investigator, will prevent patient from completing the imaging procedures
5. Other contraindications to MRI according to institutional policy
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Royal Brisbane and Women's Hospital Metro North Hospital and Health Service Butterfield Street Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12617000593336

Contact person for information and recruitmentDr
Nicholas Weber
Cancer Care Services Royal Brisbane and Women's Hospital Butterfield Street Herston QLD 4029
+61 7 3646 8111

Further information iconnicholas.weber@health.qld.gov.au
Australia

Orthotopic heart transplantation followed by autologous stem cell transplantation in patients with cardiac AL amyloidosis - a Phase II study

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Trial Information

Trial summary

This study aims to investigate the safety and efficacy of autologous stem cell transplantation  in AL amyloid patients with advanced cardiac disease. 
after a orthotopic heart transplantation. 
Who is it for?
You may be eligible to join this study if you are aged between 18-65 years and have been diagnosed with cardiac AL amyloidosis. 

Study details
All participants in this study are required to  have previously received chemotherapy and a orthotopic heart transplantation before being enrolled in the study to  received an autologous stem cell transplantation.  Patients will  undergo autologous stem cell transplantation (ASCT) within 3-6 months after OHT. 

patient will have an Autologous stem cell transplant using Melphalan 200mg/m2 on day -1 with stem cell collected given on day 0 previously from the patient before the study. 

All participants will be followed up every 3 to 6 months for a period of 5 years, in order to assess survival, and safety and efficacy of treatment.

This pilot study will determine if treating patient with a stem cell transplant  with cardiac amyloid after receiving  a heart transplant will increase disease free survival 

Broad Health ConditionAL amyloidosis with cardiac involvement

Specific Health ConditionCancer
Myeloma
Cardiovascular
Other cardiovascular diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Cardiac AL Amyloidosis, Stage III (a) or (b) prior to heart transplantation
2.	received orthotopic heart transplantation
3.	adequate cardiac function: Ejection fraction > 50%, no restrictive cardiomyopathy in echocardiogram or cardiac MRI
4.	absence of cardiac rejection
5.	no evidence of amyloid infiltration to the cardiac allograft
6.	Measurable light chains prior to induction chemotherapy (FLC > 1.5xULN with abnormal kappa:lambda ratio)
7.	Measureable	NT-ProBNP	and	Troponin-T	prior	to	induction chemotherapy
8.	ECOG status of less than 2 or Karnofsky score less than 60 (see appendix B)
9.	Able to provide informed consent

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Amyloidosis other than AL Amyloidosis. This includes AA amyloidosis, senile amyloidosis, heritable amyloidosis (including but not limited to transerythin (ATTR) cardiac amyloidosis). Patients will require a negative genetic screen for heritable amyloidosis at Westmead Hospital Amyloid unit.
2.	Diagnosis of multiple myeloma with more than 20% bone marrow plasma cells with end-organ involvement
3.	Diagnosis of other haematological or solid organ malignancies
4.	Other Amyloidosis-related end-organ diseases including renal disease (creatinine greater than 2x ULN), hepatic failure (AST, ALT greater than 3x ULN, Bilirubin > 2x ULN)
5.	Significant cytopenias: Haemoglobin level <80g/L, neutrophil count <1x109/L, platelet count <75x109/L
6.	Hepatitis B, C or HIV seropositivity
7.	Pregnancy or breastfeeding
8.	Patient with other serious medical or psychiatric illness likely to interfere with participation in this clinical study
9.	Greater than grade 1 peripheral neuropathy
10.	Smoking or intravenous drug use within 6 months of potential cardiac transplant
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital Sydney
Primary Sponsor Address: 390 Victoria St, Darlinghurst NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12617000215325

Contact person for information and recruitmentDr
Kris Ma
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
+61 2 9355 5656
+61 2 9355 5735
Further information iconSVHS.CancerResearch@svh.org.au
Australia

A randomized phase 2 study of bortezomib, cyclophosphamide and dexamethasone induction (VCD) compared with VCD and daratumumab induction followed by daratumumab maintenance (VCDD) for the initial treatment of transplant ineligible patients with multiple myeloma.

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Trial Information

Trial summary

The primary purpose of this trial is to assess whether the addition of datatumumab to a velcade, cyclophosphamide and dexamethasone treatment regime will cause an improvement in disease progression free survival.
Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant.
Study details
Eligible participants will be assigned to either a velcade, cyclophosphamide and dexamethasone (VCD) or velcade, cyclophosphamide, dexamethasone and daratumumab (VCDD) treatment arm. Both arms will receive 9 35 day cycles of treatment with the VCDD arm continuing on daratumumab maintenance monthly until disease progression, unacceptable toxicity, or withdrawal of consent. Paricipants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.
It is hoped that the findings of this trial will establish the benefits of daratumumab in combination with VCD for the treatment of multiple myeloma patients early in the course of their disease. 

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Alfred - Prahran

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Gold Coast Hospital - Southport

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Box Hill Hospital - Box Hill

Hospital
Flinders Medical Centre - Bedford Park

Hospital
St Vincent's Private Hospital - Fitzroy

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
The Canberra Hospital - Garran

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Icon Cancer Care South Brisbane - South Brisbane

Hospital
Icon Cancer Care Wesley - Auchenflower

Hospital
Icon Cancer Care Chermside - Chermside

Hospital
Icon Cancer Care Southport - Southport

Hospital
Icon Cancer Care Townsville - Hyde Park

Hospital
Icon Integrated Cancer Centre North Lakes - North Lakes

Hospital
Icon Cancer Care Adelaide - Kurralta Park

Hospital
Blacktown Hospital - Blacktown

Postcode
3004 - Prahran

Postcode
4102 - Woolloongabba

Postcode
2065 - St Leonards

Postcode
4215 - Southport

Postcode
5000 - Adelaide

Postcode
2298 - Waratah

Postcode
3128 - Box Hill

Postcode
5042 - Bedford Park

Postcode
3065 - Fitzroy

Postcode
3220 - Geelong

Postcode
2605 - Garran

Postcode
4029 - Herston

Postcode
4101 - South Brisbane

Postcode
4066 - Auchenflower

Postcode
4032 - Chermside

Postcode
4812 - Hyde Park

Postcode
4509 - North Lakes

Postcode
5037 - Kurralta Park

Postcode
2148 - Blacktown

Anticipated date of first participant enrolment31/03/2017

Anticipated date of last participant enrolment31/12/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Male or female patients 18 years or older.
2. Patients must have a diagnosis of symptomatic multiple myeloma as per IMWG criteria
3. Measureable disease
4. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplantation
5. Patients must be untreated apart from a brief course of corticosteroids or radiotherapy
6. No contraindication to the use of any of the study drugs
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 
8. Patients must meet the following clinical laboratory criteria:
a. ANC greater than or equal to  1.0 times 10 to the power of 9 per litre  (G-CSF use is permitted)
b. Platelet count greater than or equal to 70 times 10 to the power of 9 per litre for subjects in whom less than 50 percent of bone marrow nucleated cells are plasma cells; otherwise platelet count greater than 50 times 10 to the power of 9 per litre
c. Total bilirubin less than or equal to  2 times upper limit of normal (ULN), except in subjects with Gilbert syndrome, then direct bilirubin  less than or equal to 2 times ULN
d. ALT and AST less than or equal to 5 times ULN
9. Voluntary written consent 
10. Female patients who are postmenopausal or agree to use effective contraception
11. Male patients who agree to use effective contraception
12. Study site must be able to get correlative samples to the Alfred Hospital, Melbourne, Australia, within 24 hours of collection

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Patients with Amyloid light-chain (AL) amyloidosis, monoclonal gammopathy of uncertain significance or smouldering MM.
2. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 
3. Patient has greater than or equal to Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
4. Subject has significant airways disease according to the following definitions:
a. Subject has known chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume in 1 second (FEV1) less than 50 percent of predicted normal. 
b. Subject has had known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
5. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, New York Heart Association (NYHA) class 3 or 4 heart failure symptoms, unstable angina, or myocardial infarction within the past 6 months.
6. Known ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
7. Active malignancy with the exception of any of the following:
a. Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer
b. Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for 2 years
c. Stage I prostate cancer that does not require treatment
d. Any other cancer from which the subject has been disease-free for greater than or equal to 2 years
8. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
9. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
10. Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Alfred Health
Primary Sponsor Address: Alfred Hospital, 55 Commercial Road, Melbourne, VIC, 3004
Primary Sponsor Country: Australia

Trial IDACTRN12617000202369

UTNU1111-1192-2799

Contact person for information and recruitmentMs
Nola Kennedy
Alfred Health, Commercial Road, Melbourne, Victoria, 3004
+61 3 90762217
+61 3 90765531
Further information iconn.kennedy@alfred.org.au
Australia

A Trial to evaluate treatments for patients with haematological disease who also have low levels of immunoglobulins (antibodies) in the blood (hypogammaglobulinemia).

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Trial Information

Trial summary

The aim of this study is to examine whether oral antibiotics can be used instead of intravenous immunoglobulin (IVIg) to reduce the risk of infections in people with blood cancers. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have an acquired hypogammaglobulinaemia secondary to a haematological malignancy.

Study details
Participants will be randomised (allocated by chance) to one of two treatment groups in a 2:1 ratio meaning that you are twice as likely to receive intervention treatment. Participants in one group (intervention) will receive co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg orally once a day or doxycycline 100mg once daily for those hypersensitive to co-trimoxazole. Participants in the second group (control) will receive standard care treatment with intravenous or subcutaneous immunoglobulin (IVIg or SCIg) in accordance with national Criteria: Monthly (every 4 weeks +/- 1 week) dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age specific serum IgG reference range. 

The duration of each treatment is for 12 months from study entry, or until the treating physician determines that the patient should come off the treatment.

The following data will be collected: Patient demographics (age, gender, diagnosis, stage of disease), baseline investigations (including IgG levels), grade 3 or 4 infections and other clinically significant infections – at monthly intervals for 12 months. 

This project aims to improve how we use IVIg in Australia by asking: Are prophylactic (preventive) oral antibiotics equivalent to immunoglobulin 

Broad Health Conditionhaematological malignancy
hypogammaglobulinemia

Specific Health ConditionCancer
Myeloma
Cancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Leukaemia - Chronic leukaemia

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,TAS,WA,VIC

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Concord Private Hospital - Concord

Hospital
Fiona Stanley Hospital - Murdoch

Hospital
The Canberra Hospital - Garran

Hospital
Royal Hobart Hospital - Hobart

Postcode
3168 - Clayton

Postcode
2137 - Concord

Postcode
6150 - Murdoch

Postcode
2605 - Garran

Postcode
7000 - Hobart

Trial location outside Australia

Country
New Zealand

State
Wellington, Capital & Coast District

Country
New Zealand

State
Waikato

Anticipated date of first participant enrolment1/02/2017

Anticipated date of last participant enrolment1/01/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients are eligible for this trial if:
1  Age greater than or equal to 18 years 
2  Acquired hypogammaglobulinaemia secondary to a haematological malignancy 
3  Meet the Australian National Blood Authority Criteria for the Clinical Use of intravenous immunoglobulin (IVIg) for secondary hypogammaglobulinaemia (i.e. total IgG below local lower limit of reference range [excluding paraprotein] and history of recurrent or severe bacterial infection(s) OR IgG < 4 g/L [excluding paraprotein]) 
4  Life expectancy > 12 months.
5  Willing and able to attend for monthly IVIg infusion or to self-administer subcutaneous immunoglobulin.
6  Able to give informed consent to participate.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients will not be eligible for this study if they fulfil any of the following criteria:
1   Patient unwilling or unable to give informed consent.
2   llogeneic haematopoietic stem cell transplantation recipient.
3   Patient has an objection to receiving immunoglobulin.
4   Known severe IgA deficiency 
5   History of anaphylactic reaction to human immunoglobulin preparation
6   Patient already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection. Patients receiving dapsone or intermittently-dosed cotrimoxazole for PJP prophylaxis are not excluded from the study. 
7   Patient has received immunoglobulin replacement in the preceding 3 months
8   Current active infection requiring systemic antimicrobial agents
9   Anticipated prolonged significant cytopenias, defined by neutrophils < 0.5 x10^9/L or platelets < 50 x10^9/L, precluding regular cotrimoxazole. Temporary cytopenia/s due to therapy are not an exclusion.
10  History of epilepsy 
11   Pregnant or breastfeeding
12   Severe renal impairment (creatinine clearance of <30ml/min)
13   Previous splenectomy
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Monash University
Primary Sponsor Address: Wellington Road, Clayton VIC 3800
Primary Sponsor Country: Australia

Trial IDACTRN12616001723471

Contact person for information and recruitmentDr
Zoe McQuilten
Monash University Department of Epidemiology and Preventive Medicine The Alfred Centre 99 Commercial Road Melbourne, VIC 3004
+61 3 99030379

Further information iconzoe.mcquilten@monash.edu
Australia

A Phase IIb, open label, sequential cohort study comparing KappaMab alone to KappaMab in combination with lenalidomide and low dose dexamethasone (MRd) in Relapsed Refractory Multiple Myeloma

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate the safety and efficacy of KappaMab in combination with Lenalidomide and Dexamethasone for the treatment of relapsed/refractory multiple myeloma.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over with relapsed/refractory kappa restricted multiple myeloma for which you have received Received 1-3 prior lines of therapy.

Study details
Half of the participants in the study will be administered KappaMab only and half will be administered with KappaMab in combination with Lenalidomide and Dexamethasone. KappaMab will be administered weekly for the first eight weeks of study and every 28 days therafter. Lenalidomide will be taken for the first 28 days of study and the first 21 days of cycle 2. Dexamethasone will be taken weekly for the duration of the study. Participants will have blood samples taken once per month along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.

It is hoped that the findings of this trial will establish the benefits of a KappaMab and Lenalidomide based immune-oncology approach for the treatment of multiple myeloma patients relatively early in their disease course. 

Broad Health ConditionRelapsed/Refractory Multiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
The Alfred - Prahran

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Frankston Hospital - Frankston

Postcode
3004 - Prahran

Postcode
3065 - Fitzroy

Postcode
3168 - Clayton

Postcode
5042 - Bedford Park

Postcode
3000 - Melbourne

Postcode
3199 - Frankston

Anticipated date of first participant enrolment5/09/2016

Anticipated date of last participant enrolment1/08/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Age 18 years and above.

2. Confirmed diagnosis of MM as per IMWG criteria,

3. ECOG performance status 0-2

4. Relapsed and/or refractory kappa restricted MM

5. Received 1-3 prior lines of therapy
    a. Induction + ASCT + maintenance = 1 line of therapy
    b. (No prior lenalidomide therapy)

6. Adequate liver and kidney function (<2 x institutional upper limit of normal)

7. Platelet count > 75 x 10^9/L, absolute neutrophil count > 1.0 x 109/L

8. No contraindication to the use of KappaMab, lenalidomide or dexamethasone

9. Patient has voluntarily agreed and has given written informed consent.

10. Life expectancy of > 8 weeks

11. Patient must be > 2 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug

12. All females of childbearing potential (FOCBP)** must agree to have two medically supervised negative pregnancy tests : one at screening, patient undertaking contraceptive controls and one 24 hours prior to dosing of study drug. Patient must use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide

13. All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Patients with monoclonal gammopathy of uncertain significance.

2. Primary amyloidosis

3. Patients who have received prior allogeneic transplantation

4. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

5. Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma or in situ cancer of the cervix).

6. Pregnant or lactating women.

7. Known hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy or autoimmune disease
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Dr Andrew Spencer - Alfred Hospital
Primary Sponsor Address: Alfred Hospital, 55 Commercial Road, Melbourne, VIC, 3004
Primary Sponsor Country: Australia

Trial IDACTRN12616001164482

UTNU1111-1186-3669

Contact person for information and recruitmentMs
Nola Kennedy
Alfred Health, Commercial Road, Melbourne, Victoria, 3004
+61 3 90762217
+61 3 90765531
Further information iconn.kennedy@alfred.org.au
Australia

A Multicentre Phase 3 Trial Comparing Elotuzumab-Cyclophosphamide-Thalidomide-Dexamethasone (E-CTD) with Cyclophosphamide-Thalidomide-Dexamethasone (CTD) for the Treatment of Relapsed and/or Refractory Multiple Myeloma (RRMM)

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Trial Information

Trial summary

PURPOSE
The primary purpose of this study is to determine the efficacy and safety of elotuzumab when combined with cyclophosphamide, thalidomide and dexamethasone (E-CTD) when compared to a standard cyclophosphamide, thalidomide and dexamethasone (CTD) triplet for the treatment of relapsed and/or refractory multiple myeloma (RRMM)

WHO IS IT FOR?
You may be eligible to join this study if you are over 18 years, have been diagnosed with RRMM, have had between 1-3 prior lines of therapy (may include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy), and do not have central nervous system involvement with the disease.

STUDY DETAILS
Enrolled participants who meet the eligibility criteria at registration will be randomised in a 2:1 ratio with 2 patients randomised to the E-CTD arm for every 1 patient randomised to the CTD arm.  Treatment in both arms will include a combination of weekly intravenous infusions, and daily and weekly oral tablets.  Patients will receive treatment in 28 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent.  Patients will be followed up every 4 weeks for MM response until disease progression, and then every 12 weeks for survival.  The trial duration is estimated at approximately 4.75 years.

OUTCOMES
It is hoped that the findings of this trial will determine whether the addition of elotuzumab to a standard cyclophosphamide, thalidomide and dexamethasone triplet will improve progression free survival in relapsed and/or refractory multiple myeloma patients

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Alfred - Prahran

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
The Canberra Hospital - Garran

Hospital
The Tweed Hospital - Tweed Heads

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Tamworth Rural Referral Hospital - Tamworth

Hospital
Calvary Mater Newcastle - Waratah

Postcode
3004 - Prahran

Postcode
2485 - Tweed Heads

Postcode
2340 - Tamworth

Postcode
2298 - Waratah

Trial location outside Australia

Country
New Zealand

Anticipated date of first participant enrolment24/10/2016

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Male or female patients 18 years or older.
2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3. Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 120 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
4. Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
5. Patients must abide by thalidomide pregnancy prevention programme
6. Patients must have a diagnosis of a relapsed/refractory multiple myeloma as per IMWG criteria
7. Patients have had between 1-3 prior lines of therapy
- May include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy)
8. No contraindication to the use of any of the study drugs
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 
10. Patient must be greater or equal to 2 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug
11. Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm3 and platelet count greater than or equal to 75,000/mm3.  Subjects who fail screening due to neutropenia or anaemia will not be permitted to use growth factors to become eligible.  Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrolment. 
- Total bilirubin less than or equal to 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than or equal to 3 x ULN.
- Calculated creatinine clearance greater than or equal to 30 mL/min

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Known thalidomide refractory disease or intolerance
2. Patients with monoclonal gammopathy of uncertain significance or smouldering MM.
3. Patients with primary amyloidosis
4. Patients who have had a prior allogeneic transplantation that requires ongoing immunosuppressive therapy
5. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 
6. Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the reversible effects of prior chemotherapy.
7. Major surgery or radiotherapy within 14 days before enrolment.
8. Central nervous system involvement.
9. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrolment.
10. Patients who are either contraindicated or unwilling to receive anticoagulation therapy
11. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, New York Heart Association (NYHA) class 3 or 4 heart failure symptoms, unstable angina, or myocardial infarction within the past 6 months.
12. Known ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive, other immunosuppressive therapy or autoimmune disease.
13. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
14. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
15. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of the oral study medications including difficulty swallowing.
16. Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease.  Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
17. Patient has greater than or equal to Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
18. Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Leukaemia and Lymphoma Group (ALLG)
Primary Sponsor Address: Ground Floor, 35 Elizabeth Street North Richmond, VIC, 3121
Primary Sponsor Country: Australia

Trial IDACTRN12616001030460

Contact person for information and recruitmentMs
Delaine Smith
Australasian Leukaemia and Lymphoma Group (ALLG) Ground Floor, 35 Elizabeth Street, North Richmond, VIC, 3121
+613 8373 9701
+613 9429 8277
Further information icondelaine.smith@allg.org.au
Australia

A Phase 3 trial of thalidomide-dexamethasone consolidation versus thalidomide-dexamethasone-Ixazomib consolidation for transplant eligible multiple myeloma patients undergoing a single autologous stem cell transplantation as part of front-line therapy

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Trial Information

Trial summary

PURPOSE
The primary purpose of this study is to determine the efficacy and safety of the addition of ixazomib and low dose dexamethasone maintenance therapy for transplant-eligible multiple myeloma (MM) patients who are undergoing single autologous stem cell transplantation (ASCT) as part of front-line therapy.

WHO IS IT FOR? 
You may be eligible to join this study if you are aged over 18 years, have been diagnosed with symptomatic MM as per International Myeloma Working Group (IMWG) criteria, are eligible for front-line melphalan conditioned autologous stem cell transplant (ASCT), and do not have central nervous system involvement with the disease (MM).

STUDY DETAILS
Enrolled participants who have achieved clinical and haematological recovery following ASCT will undergo screening for study eligibility no earlier than 75 days following ASCT, complete screening within 15 days, and be randomised into treatment arms no later than 115 days after ASCT.

Participants will then be randomised 1:1 to the control arm (thalidomide + dexamethasone), or the experimental arm (thalidomide + dexamethasone + ixazomib), for a maximum of 12 months or until the disease progresses, whichever occurs first.

Outcomes
It is hoped that the findings of this trial will provide information on:
1.	Whether the addition of ixazomib to standard maintenance therapy will improve progression free survival in multiple myeloma patients who have undergone ASCT as part of front-line therapy; and
2.	Provide information on the safety and efficacy of ixazomib addition to standard maintenance therapy.

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Alfred - Prahran

Hospital
Box Hill Hospital - Box Hill

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Tweed Hospital - Tweed Heads

Hospital
Royal Hobart Hospital - Hobart

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
3004 - Prahran

Postcode
3128 - Box Hill

Postcode
4102 - Woolloongabba

Postcode
2485 - Tweed Heads

Postcode
7000 - Hobart

Postcode
2010 - Darlinghurst

Trial location outside Australia

Country
New Zealand

Anticipated date of first participant enrolment1/09/2016

Anticipated date of last participant enrolment12/01/2020

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:
1.	Male or female patients 18 years or older. 
2.	Voluntary written informed consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3.	 Patients must have a diagnosis of a symptomatic MM as per IMWG criteria and be eligible for front-line melphalan conditioned ASCT, with > 2x 10^6 CD34/Kg available for ASCT.
4.	Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from 4 weeks before the start of study treatment and during the entire study treatment period and through 90 days after the last dose of the study drugs, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject.  (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
5.	Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 
6.	Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) >= 1,000/mm^3 and platelet count >= 75,000/mm^3.  Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
- Total bilirubin <= 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x ULN.
- Calculated creatinine clearance >= 30 mL/min per Cockcroft-Gault equation.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
1.	Female patients who are lactating or have a positive serum pregnancy test during the screening period. 
2.	Failure to have fully recovered (i.e., <= Grade 1 toxicity) from the reversible effects of prior chemotherapy.
3.	Progressive disease post-ASCT
4.	Failure of haemopoietic recovery post-ASCT
5.	Major surgery within 14 days before enrolment.
6.	Radiotherapy within 14 days before enrolment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
7.	Central nervous system involvement with the disease under study (myeloma).
8.	Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrolment.
9.	Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
10.	Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort.
11.	Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
12.	Any serious medical or psychiatric condition (including uncontrolled infection) that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol or would be a contraindication to consolidation/maintenance therapy
13.	Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
14.	Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
15.	Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease.  Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
16.	Patient has >= Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.
17.	Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. 
18.	Contraindication to the use of either thalidomide, ixazomib or dexamethasone
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Leukaemia and Lymphoma Group (ALLG)
Primary Sponsor Address: Ground Floor, 35 Elizabeth Street, Richmond Melbourne, Victoria, 3121
Primary Sponsor Country: Australia

Trial IDACTRN12616000772448

Contact person for information and recruitmentProf
Andrew Spencer
Department of Clinical Haematology Alfred Health 55 Commercial Road Melbourne Victoria 3004
+61390763393

Further information iconaspencer@netspace.net.au
Australia

Single arm, multicentre study of Carfilzomib in combination with Thalidomide and Dexamethasone (CaTD) in patients with relapsed and/or refractory multiple myeloma (RRMM).

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Trial Information

Trial summary

The primary purpose of this study is to determine the efficacy and safety of carfilzomib-thalidomide-dexamethasone (CarTD) therapy for relapsed and/or refractory multiple myeloma (RRMM) patients. Who is it for? You may be eligible to join this study if you are aged over 18 years, have RRMM and have received between one and three lines of therapy previously. Study details The study will recruit participants in Australia and Singapore. All participants will receive 12 x 4-week cycles of CarTD therapy followed by 6 cycles of carfilzomib-dexamethasone only. The first 10 participants recruited in each country will receive a low dose for their first 3 cycles. Depending on the toxicity observed in these participants' first 2 cycles, a higher dose may then be used for their remaining cycles (cycle 4 onwards) and for all cycles in newly recruited participants. Patients will be monitored for myeloma response and safety and tolerability of CarTD therapy using blood samples and by reviewing adverse events that occur as well as for disease progression and survival information for 1 year following the last patients final cycle of treatment. It is hoped that the findings of this trial will provide an evaluation of the efficacy and safety of CarTD therapy in RRMM patients who have relapsed after prior treatment for multiple myeloma.

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Concord Repatriation Hospital - Concord

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Royal Hobart Hospital - Hobart

Hospital
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne

Hospital
Border Medical Oncology - Albury

Hospital
Royal Darwin Hospital - Tiwi

Postcode
6009 - Nedlands

Postcode
2139 - Concord

Postcode
3000 - Melbourne

Postcode
5000 - Adelaide

Postcode
7000 - Hobart

Postcode
2640 - Albury

Postcode
0810 - Tiwi

Trial location outside Australia

Country
Singapore

Country
Korea, Democratic People's Republic Of

Anticipated date of first participant enrolment30/09/2015

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male and female patients, > or =18 years of age
2.	Relapsed and/or refractory multiple myeloma at study entry.
3.	Patients must have evaluable multiple myeloma with at least one of the following (assessed within 21 days prior to registration):
a.	Serum M-protein > or = 5 g/L, or
b.	Urine M-protein > or = 200 mg/24 hour, or
In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum k/l ratio or
For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) > or = 7500 mg/L (7.5 g/L).
4.	Received at least one, but no more than three prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
5.	 Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
6.	Adequate hepatic function within 28 days prior to registration with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
7.	Left Ventricular Ejection Fraction (LVEF) > or = 40%.
8.	Absolute neutrophil count (ANC) > or = 1000/mm3 (or 1000 cells/microL) within 21 days prior to registration. Screening ANC should be independent of growth factor support for > or = 1 week.
9.	Platelet count > or = 50,000 cells/mm^3 (> or = 30,000 cells/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to registration. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
10.	Calculated or measured creatinine clearance (CrCl) of > or =15 mL/min within 21 days prior to registration. Calculation should be based on the Cockcroft and Gault formula 
11.	Written informed consent in accordance with federal, local, and institutional guidelines.
12.	Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test within 21 days prior to registration and agree to use an effective method of contraception during and for 3 months following last dose of drug.
13.	Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to registration, with the exception of dexamethasone up to 160mg or equivalent every 4 weeks.
2.	Previous treatment with carfilzomib.
3.	Focal radiation therapy within 7 days prior to registration. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to registration (i.e., prior radiation must have been to less than 30% of the bone marrow).
4.	Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to registration.
5.	Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to registration.
6.	Known HIV seropositive and/or untreated hepatitis B (patients with hepatitis B surface antigen [HBsAg] and core antibody [HBcAb] are eligible if receiving adequate antiviral therapy directed at hepatitis B).
7.	Patients with known cirrhosis.
8.	Active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.
9.	Female patients who are pregnant or lactating.
10.	Known history of allergy to Captisol (registered trademark) (a cyclodextrin derivative used to solubilise carfilzomib)
11.	Patients with hypersensitivity to carfilzomib, velcade, boron, or mannitol.
12.	Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to registration.
13.	Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to registration.
14.	Any other clinically significant medical disease or psychiatric condition that, in the Investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australiasian Leukaemia and Lymphoma Group
Primary Sponsor Address: Ground Floor, 35 Elizabeth Street, North Richmond, Victoria, 3121
Primary Sponsor Country: Australia

Trial IDACTRN12615000818538

Contact person for information and recruitmentDr
Hang Quach
Department of Haematology, St. Vincent’s Hospital Melbourne 41 Victoria Parade, Fitzroy VIC 3065
+61 3 9288 2030

Further information iconHANG.QUACH@svha.org.au
Australia

A Phase 2 Clinical Trial of Dichloroacetate in Plateau Phase Myeloma - DiCAM

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Trial Information

Trial summary

This study aims to determine whether 3 months of treatment with oral dichloroacetate can supress multiple myeloma. 

Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Plasma Cell Myeloma which is in a 'Plateau-Phase', i.e. a period of neither progression nor response at least 28 days following the last change in myeloma treatment. 

Study details: All participants in this study will be treated with a drug called dichloroacetate. This will be taken orally (by mouth) daily for 3 months A number of blood samples will be taken throughout treatment in order to determine how the body responds to treatment. This information will help us determine how well dichloroacetate is tolerated, and whether it has the ability to suppress multiple myeloma. 

Broad Health ConditionPlasma Cell Myeloma (aka Multiple Myeloma)

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT

Hospital
The Canberra Hospital - Garran

Postcode
2605 - Garran

Anticipated date of first participant enrolment16/03/2015

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

*Diagnosis of Plasma Cell Myeloma (at any time)     according to WHO criteria
*Aged 18 years or older
*Eastern Co- operative Oncology Group Performance status less than 2
*Life expectancy due to myeloma or co- morbid conditions in the opinion of the treating physician  likely to exceed 3 months 

AND 

*	has measurable residual disease i.e.
**Quantifiable serum paraprotein on electrophoresis at least 1g/L OR
**Elevated free kappa (>21mg/L) or lambda light chains (>30mg/L) AND a minimum difference between level of involved/uninvolved light chain of 150mg/L AND an abnormal serum free light chain ratio  (normal  range = 0.26-1.26) 
AND
*            is in a ‘Plateau- Phase’ i.e.
** A period of neither progression nor response at least 28 days following the last change in myeloma treatment 
**Progression defined as per IWMG 

*an increase in the paraprotein by >= 25% and at least 5g/L 

*In light chain only patients, >25% increase in difference between involved and uninvolved light chain level, with an absolute increase of >0.1g/L 

*development of new lytic lesions

*development of new end organ damage (Renal disease, marrow failure, lytic lesions, hypercalcaemia) attributable to myeloma or new plasmacytomas 

**Response defined as reduction in the paraprotein by at least 25% OR in the case of light chain only myeloma, at least 25% decrease in the difference between the involved and uninvolved light chain and  an absolute reduction of at least 100mg/L.

* Blood samples to assess for plateau phase must be at least 28 days apart

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

*Unable to give informed consent
*Non-secretory myeloma
*Receipt of any active anti-myeloma therapy (excluding bisphosphonates) in the 16 weeks prior to enrolment, with the exception that patients on stable doses of long- term maintenance therapy will be allowed (no dose alteration in the prior 8 weeks).

*Pregnant or breastfeeding
*Unwilling to avoid pregnancy and use birth control (if applicable) during the study and for 4 weeks after completion of the study
*Unable to swallow capsules
*Major surgery within the last 28 days
*Enrolled in another trial or have discontinued from another clinical trial within the last 14 days
*Any  serious pre-existing medical condition that, in the opinion of the study doctor would keep you from being on this trial
*Any peripheral motor or sensory neuropathy, neuralgia or paraesthesia (of grade 3 or worse)
*Any pre-existing severe ataxia or tremor (grade 3 or worse)
*Known history of liver disease (cirrhosis established by imaging studies or biopsy) or abnormal liver function tests within the last 14 days (AST or ALT > 3 x ULN or ALP >2.5 x ULN or total bilirubin > 1.5 x ULN)
*Any more than moderate renal impairment i.e. Calculated Creatinine Clearance by Cockcroft Gault formula of  greater than or equal to 30 mL/min 
*Inadequate cardiac function defined as:
**Electrocardiographic (ECG) evidence of 
***Acute ischemia
***Active clinically significant conduction system abnormalities
***>Grade 2 (>480 ms) (QTc) prolongation
***Uncontrolled angina or severe ventricular arrhythmias
***Myocardial infarction within the last 6 months
***Class 3 or higher New York Heart Association Congestive Heart Failure

*Haematological
**Haemoglobin < 80g/L
**Absolute Neutrophil Count (ANC) less than 1.0 x 10^9/L
**Platelet Count less than 50 x 10^9/L
*Any active fungal, bacterial and/or known active viral infection including HIV or hepatitis (A, B, or C).
*A second malignancy which in the opinion of the investigator may affect the interpretation of results
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Haematology - Capital Region Cancer Services- The Canberra Hospital
Primary Sponsor Address: Capital Region Cancer Services Building Level 5 Yamba Dr, GARRAN ACT 2602
Primary Sponsor Country: Australia

Trial IDACTRN12615000226505

UTN U1111-1166-4468

Contact person for information and recruitmentDr
Samuel Bennett
Haematology Department Capital Region Cancer Services Yamba Dr, GARRAN ACT 2602
+61 2 6174 8547

Further information iconsamkbennett@gmail.com
Australia

Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia (PAC326)

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Trial Information

Trial summary

This study will compare the chemotherapy drug, Pacritinib, against the best available treatment for Thrombocytopenia and Myelofibrosis. You may be eligible to join this study if you aged 18 years or above and have been diagnosed with thrombocytopenia and/or myelofibrosis. Participants in this study are randomly allocated (by chance) to one of three groups. Participants in the first group will receive one dose of 400mg of oral Pacritinib for 24 weeks or until progression has occurred. Participants in the second group will receive two doses of 200mg of oral Pacritinib daily for up to 24 weeks or until progression occurs. Participants in the third group will receive best available treatment - which will be chosen by your treating physician. Participants will undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans to determine spleen volume and will be assessed for total symptom score using the Myeloproliferative Neoplasm Symptom Assessment Form 2.0. These assessments will occur 12 weekly. Patients may crossover from the BAT (Best available treatment) arm to Pacritinib at the discretion of the Investigator.

Broad Health ConditionPrimary Myelofibrosis

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,WA,VIC

Trial location outside Australia

Country
New Zealand

Country
United States of America

Country
France

Country
United Kingdom

Country
Spain

Country
Hungary

Anticipated date of first participant enrolment1/07/2014

Anticipated date of last participant enrolment30/06/2015

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
Thrombocytopenia (platelet count greater than 100,000/microlitre) at any time after signing informed consent
Palpable splenomegaly greater than 5 cm on physical examination
Total Symptom Score less than 13 on the MPN-SAF TSS 2.0, not including the inactivity question
Patients who are platelet or red blood cell transfusion-dependent are eligible
Adequate white blood cell counts (with low blast counts), liver function, and renal function
At least 6 months from prior splenic irradiation
At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
Not pregnant, not lactating, and agree to use effective birth control
Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
More than 6 months of cumulative prior JAK2 inhibitor treatment
History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
Active bleeding that requires hospitalization during the screening period
Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
Life expectancy < 6 months
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Cell Therapeutics Inc.
Primary Sponsor Address: 3101 Western Avenue, Suite 600 Seattle, WA 98121
Primary Sponsor Country: United States of America

Trial websitehttp://www.celltherapeutics.com/

Trial IDACTRN12614000740695

Contact person for information and recruitmentMr
Vince Holmes
Ockham Oncology The Logan Building, Roslin Biocentre, Edinburgh, EH25 9TT United Kingdom
+44 (0)238.032.1226

Further information iconvholmes@ockham.com
United Kingdom

Phase II study assessing the effect of carfilzomib treatment on early free light chain kinetics in myeloma patients with renal impairment

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Trial Information

Trial summary

The efficacy of proteasome inhibitors (bortezomib, carfilzomib) in reversing or ameliorating renal impairment in myeloma patients has been demonstrated. The response to myeloma therapy can often be better gauged by the reduction in serum free light chains which have a shorter half-life of 3 to 5 hours, as compared with the full immunoglobulin paraprotein. The initial, very early impact on the level of free light chains is therefore likely to be critical in the effectiveness of carfilzomib in reversing renal failure. We aim to assess the effect of carfilzomib therapy on serum free light chains at very early time-points (24 and 48 hours after the day 2 dose and 24 hours after day 9 dose) following dose administration, with the aim of assessing the value of these measurements as a marker of efficacy and, in future trials, the basis on which to modify treatment regime to maximise the improvement in renal function.

Broad Health ConditionMultiple Myeloma with Renal Impairment

Specific Health ConditionCancer
Myeloma
Renal and Urogenital
Other renal and urogenital disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Hospital
Royal Prince Alfred Hospital - Camperdown

Hospital
The Alfred - Prahran

Hospital
Calvary Mater Newcastle - Waratah

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
2050 - Camperdown

Postcode
3004 - Prahran

Postcode
2298 - Waratah

Postcode
5000 - Adelaide

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment30/05/2014

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All of the following criteria must be satisfied for enrolment in the study.

Male and Female patients, >=18 years of age
Patients with newly diagnosed MM (diagnosis of MM as per IMWG –21)
Or
Multiple myeloma with relapsing or progressing disease at study entry, 
With either
Measurable M-component in serum or urine,
In patients with no detectable M-component, an abnormal FLC ratio on the Serum FLC assay
For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) >= 750 mg^dL (0.75 g^dL).

Patients with acute renal injury as the cause of reduced renal function, with creatinine clearance 15-40 ml^min at screening (calculated by the CKD-EPI and MDRD formulae)

Difference between involved and uninvolved free light chain >=300 mg^L

Adequate liver function (total bilirubin < 1.5 ULN, ALT < 2.5x ULN)

Absolute neutrophil count >= 1.0 x 109^L within one week of starting therapy.

Platelet count >= 50 x 109^L (>= 30 x 109^L if myeloma involvement in the marrow is greater than 50%) within one week of starting therapy, patients should not have received platelet transfusions within one week of the screening platelet count

Hb >= 80g^L, red cell transfusions as per institutional protocol are allowed

Subject must have LVEF >= 40%, determined by 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.

Has provided written informed consent 

Males capable of parenting a child and females of childbearing potential  must be using a medically acceptable and adequate method of contraception while undergoing protocol treatment and for 12 weeks after the last treatment

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Presence of any of the following criteria will exclude the subject from enrolment in the study.

Patients who have had myocardial infarction within 6 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities at any time.

Other uncontrolled intercurrent illness including, but not limited to, severe active infection, or psychiatric illness/social situations that would limit compliance with study requirements

Evidence of infection, dehydration or hypercalcaemia as the cause of acute kidney injury that has not been corrected.

Patients on dialysis at Screening.
	
Patients with known amyloidosis.

Patients with myelodysplastic syndrome.

Known history of allergy to Captisol (a cyclodextrin derivative used to solubilise carfilzomib)

Patients with contraindication to dexamethasone.

Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.

Women who are pregnant or lactating. Females of child-bearing potential must have a negative urine pregnancy test at Screening.

Known Hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy including dexamethasone or autoimmune disease 

Prior diagnosis of cancer that was:
more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%.
within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix.

Participation in other therapeutic studies in the last 60 days except for studies with a non-medical intervention. Documented evidence of receiving placebo will be required.

Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial. 
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australiasian Leukemia and Lymphoma Group
Primary Sponsor Address: 35 Elizabeth St, Richmond, Vic, 3121.
Primary Sponsor Country: Australia

Trial IDACTRN12614000301662

Contact person for information and recruitmentProf
Joy Ho
Institute of Haematology Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050 Australia
+61 2 9515 8031

Further information iconJoy.Ho1@health.nsw.gov.au
Australia