Trial summary

The aim of this study is to assess the immune response to the SARS-CoV-2 vaccines and the prevalence of antibodies (anti-PF4) associated with development of a rare complication of SARS-CoV-2 vaccination, thrombotic thrombocytopaenia syndrome, in patients with blood cancers compared to an elderly control population from primary care.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have a haematological disorder (including chronic lymphocytic leukaemia, lymphoma, other B cell lymphoproliferative disorders, myeloma, monoclonal gammopathy of undetermined significance, and myeloproliferative disorders) or are immunosuppressed, and are eligible to receive or have received at least 3 doses of an intramuscular SARS-CoV-2 vaccine (including Astra Zeneca (ChAdOx1), Pfizer (BNT162b2) Moderna (mRNA -1273) and Novavax) or the subcutaneous vaccine (Evusheld) as per current Australian Government Vaccine Guidelines. You may also be eligible for this study if you are aged 18 years or older, presenting to primary care without haematological disorders and have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines.

Study details
All participants will undergo SARS-CoV-2 vaccination in accordance with Australian Government Vaccine Guidelines. For those receiving intramuscular vaccination, a single blood sample for the assessment of immune response and antibody formation will be collected between Days 30 to 120 post 3rd or 4th vaccination, 6 months post 3rd or 4th vaccination (or immediately prior to additional booster vaccination), and between Days 30 to 120 post 4th or 5th vaccination. 
For those receiving subcutaneous vaccination, a single blood sample will be collected up to 7 days prior to vaccination and at Days 20 and 30 post-vaccination. 
At these timepoints, clinical reviews will also be undertaken to determine haematological malignancy diagnosis, baseline characteristics of independent variables (e.g., previous treatments) and blood parameters (e.g., full blood count).

It is hoped that this study may help to determine the immune response to the SARS-CoV-2 vaccination in this vulnerable group of patients, and will inform formulation of guidelines and treatment protocols for SARS-CoV-2 infection in the general population and immunosuppressed haematology patients.

Broad Health ConditionHaematological malignancy
Immunosuppression
COVID-19

Specific Health ConditionBlood
Haematological diseases
Cancer
Leukaemia - Chronic leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Myeloma
Inflammatory and Immune System
Other inflammatory or immune system disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Hospital
Perth Blood Institute - West Perth

Postcode
6005 - West Perth

Anticipated date of last participant enrolment1/09/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

• Age > or = 18.
• Are eligible to receive or have received at least 3 doses of the standard of care SARS-COV-2 vaccine as per current Australian Government Therapeutic Goods Administration Vaccine Guidelines. Currently in Australia vaccines choices include Astra Zeneca (ChAdOx1), Pfizer (BNT162b2) Moderna (mRNA -1273) and Novavax.
• Patients with haematology disorders including CLL (Chronic lymphocytic leukemia), lymphoma, other B cell lymphoproliferative disorders, myeloma, MGUS (Monoclonal gammopathy of undetermined significance), myeloproliferative disorders and other immunosuppressed patients.
• Patients who present to primary care without haematological disorders who have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines.
• Able and willing to provide Written and Informed Consent.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

• People with vaccine allergies.
• Pregnant or breast-feeding woman.

Trial summary

What is this study about?
We are looking at the immune response to influenza vaccine and how this can be improved in patients during or after treatment for certain types of blood cancers. When you are vaccinated, your body makes antibodies against influenza virus, which protect you from influenza infection. We know that the body’s immune response to influenza vaccine is not as strong after treatment for blood cancer. Currently, having one dose is recommended to try to protect you against influenza. 

We would like to study if two adjuvant dose influenza vaccines or two standard vaccines will improve the immune response. An adjuvant vaccine is a vaccine that contains an ingredient which can stimulate a stronger immune response and is generally used in people 65 years and above.

Who is it for?
You may be eligible to participate in this study if you are aged 18 years or older, have been receiving treatment for blood cancer (myeloma, chronic lymphocytic leukaemia or non-Hodgkins lymphoma) or have received treatment for the listed blood cancers within the last 12 months, and have not yet received a flu vaccine for the current season of recruitment (i.e. 2022 influenza vaccine for 2022 recruitment, 2023 influenza vaccine for 2023 recruitment).

Study details
There will be two groups of participants and both groups will two doses of influenza vaccine, one month apart. One group (Group 1) will receive two doses of the adjuvant influenza vaccine 1 month apart and a second group (Group 2) standard dose influenza vaccine followed by the standard dose vaccine 1 month later. 

Blood samples will be collected at four time points: before the first vaccine, before the second vaccine, 21-28 days after the second vaccine, and 6 months after the first vaccine. Participants will also be asked to provide information on vaccination history, side effects and if an influenza-like illness (ILI) occurs. Participants will be contacted weekly to see if they have developed any influenza-like illness from first vaccination until 6 months later. If respiratory symptoms occur, the participant will be asked to give a nasal swab and get checked out by their regular treating or general practitioner.

This study will help us understand if two doses of the adjuvant or standard dose vaccine should be used in patients.

Broad Health ConditionInfluenza vaccination
Haematological malignancy

Specific Health ConditionInfection
Other infectious diseases
Cancer
Myeloma
Cancer
Leukaemia - Chronic leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Postcode
3000 - Melbourne

Postcode
3084 - Heidelberg

Anticipated date of first participant enrolment1/04/2022

Anticipated date of last participant enrolment31/10/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Male and female subjects aged greater than or equal to 18 years and currently receiving or have received within last 12 months treatment for MM, CLL and NHL. Women of child-bearing potential will need to be on adequate contraception. 
2.	Willing and able to provide a blood sample just prior to vaccination, 21-28 days post each dose and roughly 6 months post-vaccination.
3.	Has not received influenza vaccine for the 2022 season 
4.	No known contraindications for influenza vaccination.
5.	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 QIV (e.g. hypersensitivity to vaccine component (including eggs)).
2.	Recent stem cell transplant (less than 12 months)
3.	Hypogammaglobulinaemia on immunoglobulin replacement
4.	Recently (within last 7 days) unwell with a fever above 38°C. 
5.     Prior participation in the study (i.e. during the 2022 enrolment year)

Trial summary

The purpose of this study is to investigate the safety of oral venetoclax treatment prior to fludarabine and cyclophosphamide non-myeloablative conditioning allogeneic stem cell transplantation for patients with haematological malignancies.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with with either acute leukaemia (myeloid and/or lymphoid, or biphenotypic), myelodysplastic syndrome, chronic lymphocytic leukaemia, B-cell non-Hodgkin lymphoma or plasma cell myeloma.

Study details:
All participants in thus study will undergo a short course of oral venetoclax between day -11 to -6 prior to fludarabine and cyclophosphamide conditioning allogeneic stem cell transplantation. The dose of venetoclax in this study will commence at 100mg daily for 5 days (total dose of 500mg), with subsequent groups increasing to a total dose of 1100mg over 5 days, 1900mg over 5 days and 2500mg over 5 days. Each participant will be assigned to received one dose level for the entire study.

The safety of venetoclax treatment will be assessed by the incidence of side effects 30 days after starting the first dose of venetoclax.

The study will determine the safest dose of venetoclax to be used prior to allogeneic stem cell transplantation for patients with haematological malignancies.

Broad Health ConditionAcute leukaemia (myeloid and/or lymphoid, or biphenotypic)
Myelodysplastic syndrome
Chronic lymphocytic leukaemia
B-cell non-Hodgkin lymphoma
Plasma cell myeloma

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

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
Peter MacCallum Cancer Centre - Melbourne

Postcode
3050 - Parkville

Postcode
3000 - Melbourne

Anticipated date of first participant enrolment28/02/2022

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

Patients are eligible for inclusion if all of the following criteria are met:

•	Age greater than or equal to 18 years
•	Planned to undergo allogeneic stem cell transplantation for one of the following haematological malignancies: acute leukaemia (including myeloid and/or lymphoid lineage or biphenotypic), myelodysplastic syndrome, chronic lymphocytic leukaemia (CLL), B-cell non-Hodgkin lymphoma (NHL) and plasma cell myeloma
•	Physician preference for a non-myeloablative conditioning regimen
•	Available 10/10 HLA-matched related or unrelated haematopoietic stem cell donor
•	Transplantation to be performed from a peripheral blood stem cell source
•	Adequate renal and hepatic function at screening as follows:
a)	Calculated creatinine clearance >50ml/min as measured by Cockroft Gault formula
b)	AST and ALT less than or equal to 3.0 x ULN
c)	Bilirubin less than or equal to 1.5 x ULN (except patients with Gilbert’s Syndrome)
•	Able to tolerate oral medications
•	Disease status at the time of transplantation as follows:
a)	Acute leukaemia in complete morphologic remission
b)	Myelodysplastic syndrome with less than 10% bone marrow blasts
c)	CLL in complete remission (CR), partial response (PR) or PR with lymphocytosis
d)	NHL in CR or PR
e)	Plasma cell myeloma in CR, very good partial response (VGPR) or PR within 3 months of prior autologous stem cell transplantation as part of a tandem auto-allo transplant approach
•	ECOG performance status 0-1

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients will be excluded from this study if any of the following criteria are met:
•	Moderate or high risk of tumour lysis syndrome (TLS) prior to conditioning for allogeneic stem cell transplantation, defined as:
a)	CLL:
•	Diameter of any lymph node or tumour mass >5cm OR absolute lymphocyte count greater than or equal to 25x10^9/L
b)	NHL:
•	Diameter of any lymph node or tumour mass >5cm
•	Prior intolerance of venetoclax or another BCL-2 inhibitor with the exception of cytopenias. Patients with prior clinical tumour lysis syndrome following venetoclax or other BCL-2 inhibitor will be excluded from the study if at the time of prior TLS their disease burden was as follows:
a)	CLL:
•	Diameter of any lymph node or tumour mass <5cm OR absolute lymphocyte count less than or equal to 25x10^9/L
b)	NHL:
•	Diameter of any lymph node or tumour mass <5cm
•	Reticulin fibrosis of the marrow of grade MF 2-3
•	Prior allogeneic stem cell transplantation
•	Haemopoietic cell transplantation – comorbidity index (HCT-CI) score > 3
•	Any currently active malignancy other than the primary indication for alloSCT (except localized basal cell carcinoma or squamous cell carcinoma of the skin)
•	Uncontrolled systemic infection
•	Known malabsorption syndrome
•	Has received within 7 days prior to the first dose of venetoclax CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin and St John’s wort
•	Has received within 7 days prior to the first dose of venetoclax CYP3A4 inhibitors
•	Known positivity to HIV
•	Significant physical or psychiatric comorbid illness that in the investigator’s opinion would impair the patient’s ability to participate in the study. 

Trial summary

This study aims to investigate whether priming intravenous administration sets with monoclonal antibodies reduces chair time.

Who is it for?
You may be eligible for this study if you are an adult being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab at the Royal Brisbane and Women's Hospital.

Study details
Participants will randomly be allocated to one of two groups: one which has their IV line primed with the treatment drug, and one which is primed with diluent only before administration of the drug. Information on treatment duration, adverse reactions and patient experience will be collected on the day.

Information from this trial will inform the optimisation of patient flow and decreased hypersensitivity reactions in oncology care.

Broad Health ConditionMyeloma
Lekaemia
Lymphoma
Lung Cancer
Melanoma

Specific Health ConditionCancer
Myeloma
Cancer
Leukaemia - Chronic leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Lung - Non small cell
Cancer
Malignant melanoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1.     Patients attending the Oncology Day Therapy Unit or Oncology Procedure Unit
2.	18 years or older
3.	Are being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab. 
4.	Any cycle of a patient’s treatment regime (e.g, 1st, 2nd, 3rd dose)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

The exclusion criteria:
1.	Under 18 years of age
2.	Patients receiving treatment with a monoclonal antibody as an inpatient or at North Lakes
3.	Patients receiving any other monoclonal antibodies that do not meet the criteria of inclusion drugs, chemotherapy, supportive therapies or treatment as part of a pharmaceutical clinical trial
4.	No funding to approach patients who require a translator 

Trial summary

This study will investigate immune responses to vaccination in patients with blood cancer who have received treatments targeting specific immune cells, B cells, those who have undergone bone marrow transplantation and a group of healthy volunteers who have not been treated for blood cancer or received any immune cell treatments.

Who is it for?
You may be eligible for this study if you are aged 18 or older, have been diagnosed with a blood cancer (including non Hodgkin's lymphoma, myeloma, Hodgkin's and leukemia) and have received either treatment with a B-cell targeted therapy or received a bone marrow transplant, and you are planning to have a COVID-19 vaccine of any variety. A second group of adults aged 18 and older who do not have a diagnosis of blood cancer or any other active cancer, who have not received treatment with B cell depleting antibodies, and who are also planning to have a COVID-19 vaccine of any variety will also be recruited.

Study details
Participants who choose to enrol in this study will be asked to provide up to five blood samples, starting up to 1 week beforethe first COVID-19 vaccine dose and continuing until 6 months after the second COVID-19 vaccine dose has been administered. We will also ask to review your medical records over the 12 months after you have received the second dose and may contact you to confirm any positive COVID-19 test results.

It is hoped this research will enable researchers to understand how these cancer treatments affect the immune response to COVID-19 vaccination and whether vaccination will provide effective protection in patients with blood cancers.

Broad Health ConditionHaematological Malignancy
Bone Marrow Transplant
COVID-19

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

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of last participant enrolment6/04/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1. Greater than or equal to 18 years of age 
2. Able to provide voluntary informed consent 
3. Planned receipt of a COVID19 vaccine of any variety; e.g. Pfizer-BioNTech BNT162b2, AstraZeneca Oxford ChAdOx1 nCoV-19 (AZD1222), Novavax NVX-CoV2373 or ModernaTX mRNA-1273 vaccine. 
- Patients who have any haematological malignancy and received treatment with a B-cell targeted therapy or who have received a bone marrow transplant may be recruited to Cohort A. 
- Patients who do not have a diagnosis of a haematological malignancy or any other active cancer, and who have not received treatment with B cell depleting antibodies will be recruited to Cohort B. 50 patients will be recruited in total, 30 to Cohort A and 20 to Cohort B. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1. Current diagnosis of and/or treatment for a non-haematological malignancy. 
2. Receipt of B cell targeted therapies for Rheumatological or other non-haematological malignancy indication 
3. Unable to provide voluntary informed consent

Trial summary

This study is investigating the perceived benefit of implementing a nurse led model of care for older myeloma patients undergoing oral cancer treatment.
Who is it for?
You may be eligible for this study if you are aged 65 years or older, you are newly diagnosed with Myeloma or first relapse and are being treated at one of the participating hospitals in South Australia.

Study details
All enrolled participants will be provided with additional education about the disease and treatment by a specialist nurse.  The specialist nurse will also act as a first point of contact during chemotherapy to answer questions and provide additional support to participants as required.  Participants will have their medical records reviewed by the specialist nurse and may be asked to complete questionnaires at various timepoints over a 12 month period.

It is hoped this research will demonstrate that a nurse led model of care for older patients with myeloma has a positive impact on their treatment completion rates and quality of life during cancer treatment.

Broad Health ConditionMyeloma

Specific Health ConditionCancer
Myeloma

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Anticipated date of last participant enrolment28/12/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

•	Diagnosis of Myeloma according to the WHO (2008) classification, aged 65years and over 
•	MGUS patients progressed to Myeloma needing treatment
•	Relapsed Myeloma patients needing treatment
•	Capacity to understand and voluntarily sign an informed consent form
•	Able to be followed at the Royal Adelaide Hospital/The Queen Elizabeth Hospital

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Primary Haematologist does not practice at the Royal Adelaide Hospital/ The Queen Elizabeth Hospital
•	patients <65 years of age
•	Any significant condition that would confound the collection or interpretation of data from the study

Trial summary

This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual and relationship education intervention for allogeneic haematopoietic stem cell transplantation (HSCT) survivors and their partners post-transplantation.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have received an allogeneic haematopoietic stem cell transplantation to treat a haematological malignancy (blood cancer) more than 3 months ago, you are in a sexual relationship and would like to receive assistance for identified sexual health issues.

Study details
All participants and their partners who choose to enrol in this study will receive one 60 minute educational session about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant. Enrolled couples will then also receive four 90 minute Emotionally Focused Therapy (EFT)-based relationship education sessions delivered by a clinical psychologist. Couples will be asked to complete a series of questionnaires before receiving the intervention sessions, and again after the final intervention session, 

It is hoped this research will demonstrate that a psychosexual intervention combining medical/behavioural management of sexual dysfunction and relationship education sessions will be feasible and helpful for patients with blood cancers. This may be used to improve sexual health outcomes for these and future patients and their partners.
 

Broad Health ConditionSexual dysfunction post-allogeneic haematopoietic stem cell treatment
haemtological cancers
haematological malignancies

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

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Postcode
3000 - Melbourne

Anticipated date of last participant enrolment1/06/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

-	Age: At least 18 years of age (both patient and partner)
-	More than 3 months post-haematopoietic transplantation to treat a haematological malignancy 
-	Patient has not relapsed since transplant
-	In a sexual relationship (same sex couples included) of at least 1 year (as reported by the patient) but couples do not need to be currently sexually active to participate in the study
-	Able to give informed consent (i.e. no psychiatric/cognitive condition that would impact informed consent, as based on clinical judgment)
-	Patient states that they have sexual health problems and would like help with these issues

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

-	Currently receiving couples counselling from a therapist not involved in the study; 
-	Partner is not willing to participate in the intervention
-	Patient has had a relapse of disease and/or has been readmitted to hospital 
-	Patient is suffering from significant ongoing side effects that might impede their participation

Trial summary

The purpose of this study is to examine the safety of completing a stem cell transplant of your own cells in the outpatient setting.
Who is it for?
You may be eligible for this study if you are aged 18 -75 and are undergoing a stem cell transplant with your own cells at Nepean Hospital.
Study Details
Participants will choose between two locations for their transplant, inpatient or outpatient. 
Inpatient participants will receive all pre-transplant, transplant and post transplant care in hospital. Inpatient participants will be discharged when they are well enough.
Outpatient participants will come to the centre for their pre-transplant chemotherapy, transplant and post transplant care but be able to stay at home between visits until they become unwell or require extra care unable to be provided at home. The outpatient participants will also take oral antibiotics after the transplant.
As part of this study, participants and their carers will complete questionnaires and consent to study staff reviewing their medical records.
It is hoped this research will show that stem cell transplant can be performed in an outpatient setting, which may improve quality of life.

Broad Health ConditionAutologous Stem Cell Transplant

Specific Health ConditionCancer
Myeloma
Public Health
Health service research

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Nepean Hospital - Kingswood

Postcode
2747 - Kingswood

Anticipated date of last participant enrolment1/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

diagnosis of multiple myeloma
to be treated with Melphalan pre-transplant
ECOG 0,1,or 2
Fit for autologous stem cell transplant at Nepean Hospital
Participant willing to participate in the trial
carer available
transport and driver available
complies with cohort distance requirements

Minimum age18 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Not fit for Autologous stem cell transplant
Unwilling to participate

Trial summary

The study aims to determine the efficacy of combination therapy with Carfilzomib and Dexamethasone and Belantamab mafodotin (BelaMaf-Kd) for patients with relapsed refractory multiple myeloma.  Belantamab mafodotin is a new drug which has not been approved for use by the Therapeutic Goods Administration and so this combination is considered an experimental treatment.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or over, and have received between 1 to 3 prior lines of therapy for multiple myeloma but have not undergone allogeneic stem cell transplantation.

Study Details
Eligible participants will receive 6 cycles of combination BelaMafKd with treatment given over a 28 day cycle as tolerated. Belantamab mafodotin and Carfilzomib will be delivered by IV infusion on days 1 and 8 and days 1, 8 and 15 respectively. Dexamethasone will be given orally weekly. 

Participants will be required to have blood samples taken and medical reviews (including ophthalmic examination) at the beginning of each cycle. An ultrasound test of cardiac function will be performed at screening and within 2 weeks of completion of cycle 6. A bone marrow biopsy will be performed at screening, at cycle 6 and to confirm a complete response or disease progression. These assessments will enable researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. 
Study treatments will be halted if participants show disease progression, unacceptable toxicity, or upon withdrawal of consent.
A final medical assessment and ophthalmic exam will be performed at end of treatment, with follow up to continue every 12 weeks until one year after the final cycle of treatment.

Follow up assessments will continue every 12 weeks until one year after the final cycle of treatment.

It is hoped that the findings of this trial will establish the benefits of Belantamab mafodotin in combination with Carfilzomib and Dexamethasone for the treatment of patients with early relapsed multiple myeloma.

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,VIC

Hospital
The Alfred - Melbourne

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

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Concord Repatriation Hospital - Concord

Hospital
Border Medical Oncology - Albury

Hospital
Flinders Medical Centre - Bedford Park

Hospital
The Townsville Hospital - Douglas

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
3004 - Melbourne

Postcode
3065 - Fitzroy

Postcode
3220 - Geelong

Postcode
5000 - Adelaide

Postcode
2298 - Waratah

Postcode
2139 - Concord

Postcode
2640 - Albury

Postcode
5042 - Bedford Park

Postcode
4814 - Douglas

Postcode
4029 - Herston

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment31/12/2020

Anticipated date of last participant enrolment31/12/2023

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Participants must have: 
1. confirmed multiple myeloma as defined by the International Myeloma Working Group criteria
2.  at least 1 and no more than 3 prior lines of therapy
3. measurable disease defined as at least one of:
a. Serum M-protein concentration of 5g/L or greater
b. Urine M-protein excretion of 200mg/24hr or greater OR
c. Serum free light chain (FLC) assay: involved FLC level  of 100mg/L or greater and an abnormal serum free light chain ration (<0.26 or >1.65)
4. Adequate organ system function:
a. Haematological: Absolute neutrophil count of 1.0x109/L or greater, Haemoglobin of80g/L or greater, Platelet count of 50x109/L or greater
b. Hepatic: ALT < 2.5xULN and Bilirubin < 1.5xULN
c. Renal: eGFR > 20ml/min
d. Cardiac: LVEF > 45%

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants must not have had/be:
1. systemic anti-myeloma therapy within 14 days with the exception of corticosteroids equivalent to dexamethasone 160mg or greater within last 4 weeks
2. prior treatment with a monoclonal Antibody within 30 days of receiving first dose of study drugs
3. prior allogeneic stem cell transplant.
4. evidence of cardiovascular risk: QTc interval of 470msec or greater; uncontrolled arrhythmias; history of myocardial infarction or acute coronary syndrome within last 6 months; class II or IV heart failure defined by New York Heart Association functional classification system.
5. Pregnant or lactating females
6. Active infection requiring treatment
7. Known HIV infection
8. Hepatitis B surface Antigen (HbsAg) or Hepatitis B core Antibody (HBcAb) positivity 
Positive hepatitis C antibody or positive hepatitis C RNA at screening or within 3 months prior to first dose of study treatment. (NOTE: participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if confirmatory negative hepatitis C RNA is obtained.)
9. Current corneal disease except for mild punctate keratopathy.
10. Known immediate or delayed hypersensitivity or unacceptable adverse effects from previous proteasome inhibitors.
11. Ongoing grade 2 or higher peripheral neuropathy
12. Known immediate or delayed hypersensitivity reaction to drugs chemically related to Belantamab Mafodotin

Trial summary

The purpose of this study is to test a new screening tool to see if this tool helps the hospital meet patient’s supportive care needs. Supportive care includes physical, financial, emotional, family and practical support.

Who is it for?
You may be eligible for this study if you are aged 16 or over, you have a diagnosis of blood cancer and are receiving treatment. You may also be eligible for a part of the study if you have received treatment for a blood cancer in the past.

Study details
Participants in this study will be divided into two groups, depending on whether they are currently having treatment (called the prospective group), or received treatment in the past (the retrospective group). Both groups will complete screening tools, which involve a questionnaire. The retrospective group will complete a paper questionnaire and return by mail. The prospective group will complete the questionnaire at each appointment in a 12-month period. In addition to the questionnaire(s), all participants will also complete a satisfaction survey.

It is hoped this research will demonstrate the usefulness of this screening process, and enable the needs of patients to be responded to more effectively.

Broad Health ConditionHaematological malignancy

Specific Health ConditionCancer
Hodgkin's
Cancer
Leukaemia - Acute leukaemia
Cancer
Leukaemia - Chronic leukaemia
Cancer
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Myeloma
Cancer
Other cancer types
Blood
Other blood disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Cabrini Hospital - Malvern - Malvern

Postcode
3144 - Malvern

Anticipated date of first participant enrolment9/03/2020

Anticipated date of last participant enrolment1/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Prospective arm:
1. Participants with a diagnosis of haematological malignancy (including, but not limited to, myeloma, lymphoma, leukaemia, myelodysplastic and myeloproliferative syndromes), attending the study centre
2. In receipt of treatment for their haematological malignancy during the twelve-month study period (including, but not limited to, parenteral chemotherapy and immunotherapy, oral chemotherapy/disease directed therapy or regular blood product transfusions)

Retrospective arm:
1. Participants with a diagnosis of haematological malignancy (including, but not limited to, myeloma, lymphoma, leukaemia, myelodysplastic and myeloproliferative syndromes)
2. Attended the study centre between 28/05/19 - 27/05/2020 for treatment of their haematological malignancy

Minimum age16 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

For both prospective and retrospective arms, patients who are unable to speak or write the English language are not eligible for participation in this study. 

Trial summary

The purpose of this study to determine whether the addition of selinexor to lenalidomide maintenance therapy post Autologous Stem Cell Transplant for multiple Myeloma patients increases the proportion of patients who are progression free 3 years post randomisation.

Who is it for?

You may be eligible for this study if you are an adult who has been newly diagnosed with Multiple Myeloma and are eligible for an Autologous Stem Cell Transplant.

Study details

Participants in this study will be randomised to receive either:
Lenalidomide 10mg,orally,once a day for 21 days
or
Lenalidomide 10mg,orally,once a day for 21 days with Selinexor 40mg,orally, weekly

Lenalidomide may be increased to 15mg orally, once a day for 21 days from cycle 4 onwards, provided good tolerance and no lenalidomide-related greater than or equal to grade 3 adverse events.

Selinexor may be maintained at 40mg orally, weekly from cycle 2 onwards provided good tolerance and no selinexor-related greater than or equal to grade 3 adverse events
Each cycle lasts 28 days,

Patients will receive treatment until disease progression.

During the trial patients will have blood tests performed and bone marrow samples taken to help determined the progress of the treatment.

It is hoped that this research will help determine whether this treatment prolongs the progression free survival for patients, and what kinds of side effects/complications may occur with this treatment.

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
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
The Alfred - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Townsville University Hospital - Douglas

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Concord Repatriation Hospital - Concord

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Border Medical Oncology - Albury

Hospital
Fiona Stanley Hospital - Murdoch

Hospital
Lismore Base Hospital - Lismore

Hospital
Orange Health Service - Orange

Hospital
Launceston General Hospital - Launceston

Hospital
Western Hospital - Footscray - Footscray

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Royal Hobart Hospital - Hobart

Postcode
3065 - Fitzroy

Postcode
3004 - Melbourne

Postcode
3084 - Heidelberg

Postcode
3220 - Geelong

Postcode
4102 - Woolloongabba

Postcode
4814 - Douglas

Postcode
3168 - Clayton

Postcode
2139 - Concord

Postcode
3000 - Melbourne

Postcode
2640 - Albury

Postcode
6150 - Murdoch

Postcode
2480 - Lismore

Postcode
2800 - Orange

Postcode
7250 - Launceston

Postcode
3011 - Footscray

Postcode
5000 - Adelaide

Postcode
2010 - Darlinghurst

Postcode
7000 - Hobart

Trial location outside Australia

Country
New Zealand

Anticipated date of first participant enrolment3/08/2020

Anticipated date of last participant enrolment18/01/2024

Phase of TrialPhase 3

Has the study received ethics approval?Approved

Key inclusion criteria

• Patient must be 18 years of age or older
• Patient has voluntarily agreed and has given written consent to both the main study and 
   correlative study
• Diagnosis of MM as per IMWG guidelines (Appendix 3)
• Must be eligible for front-line melphalan conditioned ASCT
• Will have undergone at least 3-6 cycles of up-front therapy containing a proteasome 
  inhibitor (PI) and/or immunomodulatory drug (IMID) and ASCT (tandem transplants 
  allowable) prior to screening procedures (note consent and registration will occur prior to 
  ASCT
• Pre-ASCT (preferably prior to and if not, as early as possible during induction therapy) 
   bone marrow aspirate trephine for correlative studies. Patients who are unable to provide 
   pre ASCT BMAT samples for correlative studies can be enrolled into the study if a waiver 
   is granted from the coordinating principal investigator
• Measurable disease at diagnosis:
   • Serum M-protein greater than or equal to 5 g/L, or
   • Urine M-protein greater than or equal to 200 mg/24 hour, or
   • In patients without measurable serum or M-protein, serum free light chain (SFLC) 
     greater than 100mg/L (involved light chain) and an abnormal serum k/l ratio or
   • In IgA patients whose disease can only be reliably measured by serum quantitative 
      immunoglobulin (qIgA) greater than or equal to 7500 mg/L (7.5 g/L).
• Female patients who are postmenopausal for at least 1 year prior to screening visit OR 
   surgically sterile OR agree to practice 2 effective methods of contraception at the same 
   time from 4 weeks before start of study treatment and until 90 days after the last dose of 
   study drugs OR agree to practice true abstinence when this is in line with the preferred 
   and usual lifestyle of the subject.
• Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to 
   practice effective barrier contraception during the entire study treatment period and 
   through 90 days after the last dose of study drug, OR to practice true abstinence when 
   this is in line with the preferred and usual lifestyle of the subject.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix 2).
• Subjects must agree not to donate blood, semen or sperm while on study and at least 90 
  days after treatment discontinuation.
• Subjects must agree not to share their medication and to return unused supplies.
• Patients must meet the following clinical laboratory criteria:
  o Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L and platelet count 
     greater than or equal to 100 x10^9/L. Platelet transfusions to help patients meet 
     eligibility criteria are not allowed.
  o Total bilirubin less than or equal to 1.5 x the upper limit of the normal range (ULN)
  o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal 
     to 3 x ULN.
  o Calculated creatinine clearance greater than or equal to 30 mL/min per Cockcroft-Gault 
     equation.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

• Pregnant or lactating women.
• Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the 
   reversible effects of prior chemotherapy.
• Progressive disease post-ASCT.
• Major surgery within 14 days before enrolment.
• 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 selinexor.
• Central nervous system involvement.
• Active infection requiring iv antibiotics in 5 days prior to starting study therapy.
• Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B 
  has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial 
  treatment. Subjects with untreated hepatitis C virus (HCV) are not allowed. Subjects with 
  Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts greater than or equal 
  to 350 cells/µL and no history of AIDS-defining opportunistic infections in the last year are 
  allowed.
• 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.
• Known allergy to any of the study medications, their analogues, or excipients in the 
   various formulations of any agent.
• Known GI disease or GI procedure that could interfere with the oral absorption or 
   tolerance of study medications including difficulty swallowing.
• Patient has greater than or equal to 2 grade peripheral neuropathy or grade 1 with pain on 
   clinical examination during the screening period.
• Participating 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.
• Contraindication to the use of either lenalidomide or selinexor.

Trial summary

The study utilises the infrastructure of a national clinical registry (Australian and New Zealand Myeloma and Related Diseases Registry) to enable identification of patients, efficient data collection, long-term follow-up beyond the trial and comparison with non-trial patients to assess study generalisability. 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,NT,QLD,SA,TAS,VIC

Hospital
The Alfred - Melbourne

Hospital
Calvary Mater Newcastle - Waratah

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Royal Hobart Hospital - Hobart

Hospital
Sunshine Hospital - St Albans

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Sunshine Coast University Hospital - Birtinya

Hospital
Concord Repatriation Hospital - Concord

Hospital
Tamworth Rural Referral Hospital - Tamworth

Hospital
Western Hospital - Footscray - Footscray

Hospital
Nepean Hospital - Kingswood

Hospital
Royal Darwin Hospital - Tiwi

Hospital
The Townsville Hospital - Douglas

Hospital
The Queen Elizabeth Hospital - Woodville

Hospital
Toowoomba Hospital - Toowoomba

Hospital
The Northern Hospital - Epping

Hospital
Latrobe Regional Hospital - Traralgon

Postcode
3004 - Melbourne

Postcode
2298 - Waratah

Postcode
5000 - Adelaide

Postcode
7000 - Hobart

Postcode
3021 - St Albans

Postcode
4102 - Woolloongabba

Postcode
4575 - Birtinya

Postcode
2139 - Concord

Postcode
2340 - Tamworth

Postcode
3011 - Footscray

Postcode
2747 - Kingswood

Postcode
0810 - Tiwi

Postcode
4814 - Douglas

Postcode
5011 - Woodville

Postcode
4350 - Toowoomba

Postcode
3076 - Epping

Postcode
3844 - Traralgon

Trial location outside Australia

Country
New Zealand

State
Dunedin Hospital - Southern DHB

Country
New Zealand

State
Middlemore Hospital, Auckland

Country
New Zealand

State
North Shore Hospital, Auckland

Country
New Zealand

State
Christchurch Hospital

Anticipated date of first participant enrolment15/11/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

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.

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

Hospital
North Lakes Health Precinct - North Lakes

Postcode
4120 - Greenslopes

Postcode
4102 - Woolloongabba

Postcode
4029 - Herston

Postcode
4509 - North Lakes

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?Approved

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 

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
NSW,TAS,WA,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

Hospital
Fiona Stanley Hospital - Murdoch

Hospital
St George Hospital - Kogarah

Hospital
Border Medical Oncology - Albury

Hospital
Concord Repatriation Hospital - Concord

Hospital
Calvary Mater Newcastle - Waratah

Postcode
3004 - Prahran

Postcode
3065 - Fitzroy

Postcode
3002 - East Melbourne

Postcode
7000 - Hobart

Postcode
5042 - Bedford Park

Postcode
6150 - Murdoch

Postcode
2217 - Kogarah

Postcode
2640 - Albury

Postcode
2139 - Concord

Postcode
2298 - Waratah

Anticipated date of first participant enrolment25/03/2019

Anticipated date of last participant enrolment31/03/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

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

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

Hospital
Bairnsdale Regional Health Service - Bairnsdale

Hospital
Ballarat Health Services (Base Hospital) - Ballarat Central

Hospital
Border Medical Oncology - Albury

Hospital
Calvary Mater Newcastle - Waratah

Hospital
St John of God Hospital, Geelong - Geelong

Hospital
Central Gippsland Health Service (Sale) - Sale

Hospital
Launceston General Hospital - Launceston

Hospital
Nepean Hospital - Kingswood

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Sunshine Coast University Hospital - Birtinya

Hospital
Toowoomba Hospital - Toowoomba

Hospital
Townsville University Hospital - Douglas

Hospital
Fiona Stanley Hospital - Murdoch

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

Postcode
3875 - Bairnsdale

Postcode
3350 - Ballarat Central

Postcode
2640 - Albury

Postcode
2298 - Waratah

Postcode
3220 - Geelong

Postcode
3850 - Sale

Postcode
7250 - Launceston

Postcode
2747 - Kingswood

Postcode
2010 - Darlinghurst

Postcode
4575 - Birtinya

Postcode
4350 - Toowoomba

Postcode
4814 - Douglas

Postcode
6150 - Murdoch

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 enrolment31/12/2040

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

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. 

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?Approved

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

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?Approved

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

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?Approved

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

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?Approved

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.

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?Approved

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.