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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The SerOzNET study seeks to better understand the safety and efficacy of the COVID-19 vaccines in people with cancer.

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Trial Information

Trial summary

This study will investigate the serological and immune response of cancer patients to the COVID-19 vaccine

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have not received COVID-19 vaccination, with one or more of the following criteria:

 •	Currently on chemotherapy
•	Currently on immunotherapy
•	Currently on hormonal therapy
•	Received chemotherapy 6-12 months ago
•	Have an allergy to either a vaccine or an anticancer treatment
•	Have a diagnosis of multiple myeloma, CLL, or low grade lymphoma,
        are eligible for government COVID-19 vaccination program and willing to receive the 
        vaccine

Study details
All participants in this study will have serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting) at baseline, day 7 post initial vaccination, at booster appointment, 7 days post booster and at 3 months after booster vaccination.

Administration of the vaccine itself and real-time collection/assessment/management of toxicities will not form part of the SerOzNET study. Patients will receive vaccination at their usual GP clinic or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice.

It is hoped this research will contribute to the cancer immunology field in order to assist oncologist improve health outcomes for patients with cancer.

The study involves serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting).

Broad Health ConditionCancer
Oncology
COVID-19

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

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,WA,VIC

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Monash Medical Centre - Moorabbin campus - East Bentleigh

Hospital
Dandenong Hospital - Dandenong

Hospital
Casey Hospital - Berwick

Hospital
Sydney Children's Hospital - Randwick

Hospital
The Children's Hospital at Westmead - Westmead

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Royal Perth Hospital - Perth

Postcode
3168 - Clayton

Postcode
3165 - East Bentleigh

Postcode
3175 - Dandenong

Postcode
3806 - Berwick

Postcode
2031 - Randwick

Postcode
2145 - Westmead

Postcode
2010 - Darlinghurst

Postcode
6000 - Perth

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

 Aged 12 years or over
• Able to give informed consent
• Eligible for government COVID-19 vaccination program and willing to receive the
vaccine
• Cancer diagnosis fitting one of the study cohorts (solid tumour, haematological
malignancy, currently receiving chemotherapy, currently receiving immunotherapy &
known allergic reaction to PEG or Polysorbate)

Minimum age12 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Not appropriate for serial peripheral blood collections, due to clinical reasons such as 
        severe anaemia, poor venous access or other, as determined by the patient’s  
        oncologist or haematologist.
•	Life expectancy estimated to be < 12 months
•	Individual is not able to provide informed consent
•	Pregnancy
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Monash Health
Primary Sponsor Address: 246 Clayton Road Clayton VIC 3168
Primary Sponsor Country: Australia

Trial websitehttps://www.canceraustralia.gov.au/SerOzNET-Study

Trial IDACTRN12621001004853

Contact person for information and recruitmentMs
Luxi Lal
Monash Health MHTP Clinical Trial Centre 246 Clayton Rd Clayton VIC 3168
+61428803521
+6139594 3982
Further information iconseroznet@monashhealth.org
Australia

Will priming intravenous administration sets with monoclonal antibodies reduce chair time in the outpatient setting? (The priming practice study)

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Trial Information

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?Further information iconApproved

Eligibility

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 
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 Butterfield Street, Herston QLD, 4029
Primary Sponsor Country: Australia

Trial IDACTRN12621000933853

Contact person for information and recruitmentDr
Nicole Gavin
Centre for Clinical Nursing Royal Brisbane and Women's Hospital Butterfield Street, Herston QLD, 4029
+61 7 36465833

Further information iconnicole.gavin@health.qld.gov.au
Australia

COVID-19 Vaccine Efficacy in patients with Blood Cancer

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Trial Information

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?Further information iconApproved

Eligibility

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
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Butterfield Street HERSTON QLD 4029
Primary Sponsor Country: Australia

Trial websiteN/A

Trial IDACTRN12621000538842

Contact person for information and recruitmentDr
Andrea Henden
QIMR Berghofer Medical Research Institute 300 Herston Road HERSTON QLD 4006 and Royal Brisbane and Women's Hospital Butterfield Street HERSTON QLD 4029
+61 7 3845 3968
N/A
Further information iconandrea.henden@qimrberghofer.edu.au
Australia

Analysing compliance with Calcium and Vitamin D supplementations in patients receiving bone resorptive agents.

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Trial Information

Trial summary

This observational study will examine rates of compliance with calcium and vitamin D doses prescribed to cancer patients who may benefit from taking these supplements due to the type of cancer treatment drugs they have been given.

Who is it for?
You may be eligible for this study if you are 18 or older, you are receiving cancer treatment(s) including Denosumab, Pamidronate or Zoledronic acid and you are attending one of the Icon Cancer Centres in Queensland for treatment.

Study details
All enrolled participants will be asked to complete a survey that includes questions about their current cancer treatment, and whether they have been prescribed calcium and vitamin D in addition to their cancer treatment. It is expected that the survey will take approximately 15 minutes to complete, and participants will be asked to complete this during a scheduled clinic visit, therefore additional study visits are not required.

It is hoped this research will determine the current rate of calcium and vitamin D dose compliance in patients whose cancer treatment may have a negative impact on their bone health. It is hoped this study will also identify barriers that may make it difficult for patients to maintain their calcium and vitamin D doses and will then be able to make adjustments to address these barriers.

Broad Health Conditioncancer
Multiple Myeloma
prostate cancer
bone metastasis
Breast Cancer
Other cancers with bone metastasis

Specific Health ConditionCancer
Bone
Cancer
Breast
Cancer
Prostate
Cancer
Myeloma
Cancer
Other cancer types

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Icon Cancer Care South Brisbane - South Brisbane

Hospital
Icon Cancer Care Wesley - Auchenflower

Hospital
Icon Cancer Care Southport - Southport

Hospital
Icon Cancer Care Chermside - Chermside

Postcode
4101 - South Brisbane

Postcode
4066 - Auchenflower

Postcode
4215 - Southport

Postcode
4032 - Chermside

Anticipated date of first participant enrolment3/05/2021

Anticipated date of last participant enrolment1/10/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients over the age of 18 treated at Icon Cancer Centre sites where Denosumab, Pamidronate or Zoledronic acid has been prescribed between 01/01/2021 and 01/01/2022 or until goal participant numbers have been reached. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients with hyperglycemia of malignancy; 
Patients with history of osteoporosis.
Patients participating in other clinical trials 
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: Icon Cancer Foundation
Primary Sponsor Address: Level 1 / 22 Cordellia street, South Brisbane, QLD 4101
Primary Sponsor Country: Australia

Trial websiteNot applicable

Trial IDACTRN12621000383864

Contact person for information and recruitmentMrs
Ashleigh Smith
Icon Cancer Centre Chermside - Chermside Medical Complex, 1/956 Gympie Road, Chermside QLD 4032
+61 7 3737 4500
07 3737 4801
Further information iconAshleigh.Smith@icon.team
Australia

A Pilot Study Exploring the potential benefits of Nursing Case Management In the Management of older Patients with Myeloma

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Trial Information

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?Further information iconApproved

Eligibility

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
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: BMS-celgene
Primary Sponsor Address: Level 2/4 Nexus Court Mulgrave VIC 3170 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12621000261819

Contact person for information and recruitmentDr
Cindy Lee
Royal Adelaide Hospital Haematology Port Rd Adelaide SA 5000
+61 8 7074 2356

Further information iconCindy.Lee3@sa.gov.au
Australia

A pilot study evaluating feasibility and acceptability of a psychosexual intervention for couples post-allogeneic haematopoietic stem cell transplantation

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Trial Information

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?Further information iconApproved

Eligibility

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
Contact details and further information

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

Trial IDACTRN12620001220954

Contact person for information and recruitmentDr
Brindha Pillay
Psychosocial Oncology Program Peter MacCallum Cancer Centre 305 Grattan Street, Melbourne VIC 3000
+61 3 85595265

Further information iconbrindha.pillay@petermac.org
Australia

Comparing Outpatient and Inpatient Autologous Stem Cell Transplant in Patients with Multiple Myeloma

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Trial Information

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 enrolment11/04/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

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
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Nepean Blue Mountains Local Health District
Primary Sponsor Address: Cnr Great Western Hwy and Somerset St Kingswood NSW 2747
Primary Sponsor Country: Australia

Trial IDACTRN12620000667910

UTNNil

Contact person for information and recruitmentMs
Elyssa Deakin
Nepean Cancer Care Centre Cnr Great Western Hwy and Somerset St Kingswood NSW 2747
+61 2 4734 4411

Further information iconelyssa.deakin@health.nsw.gov.au
Australia

Prehabilitation to Improve outcomes afteR Autologous sTem cEll transplantation (PIRATE) – A randomised controlled trial

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Trial Information

Trial summary

The purpose of this study is to see if providing rehabilitation (prehabilitation) before stem cell transplant builds physical strength and fitness.

Who is it for?
You may be eligible for this study if you are aged 18 of older and are on the waitlist for autologous stem cell transplant.

Study details
Participants will be randomised by chance (like flipping a coin) into two groups. One group will receive a physiotherapy assessment and standardised exercise advice in addition to standard care. The other group will attend 2 x 60 minute exercise classes per week and receive fortnightly phone calls comprising nutrition education for up to 8 weeks before their transplant. As part of this study, participants will also have a fitness and nutrition assessment, answer questionnaires, provide blood samples and consent to medical records being accessed.

It is hoped this research will demonstrate that prehabilitation builds physical strength and fitness, and this will to prevent problems after stem cell transplant, leading to faster recovery from treatment.

Broad Health ConditionCancer

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

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Box Hill Hospital - Box Hill

Postcode
3128 - Box Hill

Anticipated date of first participant enrolment30/06/2020

Anticipated date of last participant enrolment29/07/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Participants recruited from haematology clinics at Eastern Health and affilitated haematology private practices where patients will be referred to Eastern Health for Auto SCT. Participants will be eligible if they: are aged 18 years and over; have a haematological malignancy and are waitlisted for autologous stem cell transplant; and are able to give written informed consent. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants will be excluded if patients have a medical condition that contraindicates participation in an exercise-based rehabilitation program as assessed by a physiotherapist or medical practitioner. 
•	They have an Australian-modified Karnofsky Performance status of <60 or ECOG >2. 
•	They have a cognitive impairment that precludes their ability to provide written, informed consent as assessed by their treating clinician.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Eastern Health
Primary Sponsor Address: Level 2, 5 Arnold St, Box Hill Victoria 3128
Primary Sponsor Country: Australia

Trial IDACTRN12620000496910

UTNU1111-1249-5528

Contact person for information and recruitmentDr
Amy Dennett
Eastern Health Allied Health Clinical Research Office, Level 2, 5 Arnold St Box Hill Victoria 3128
+61 390952442

Further information iconamy.dennett@easternhealth.org.au
Australia

Electronic Patient Reported Outcome Measures (PROMs) in Blood Cancer Patients: A Pilot Study

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Trial Information

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?Further information iconApproved

Eligibility

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. 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Cabrini Hospital
Primary Sponsor Address: 183 Wattletree Rd Malvern VIC 3144
Primary Sponsor Country: Australia

Trial IDACTRN12620000303943

UTNU1111-1248-5402

Contact person for information and recruitmentA/Prof
Melita Kenealy
Cabrini Hospital CHOC Level 2, 183 Wattletree Rd Malvern VIC 3144
+61 3 9500 9345

Further information iconmelita.kenealy@thebloodunit.com.au
Australia

An ALLG Trial to compare the use of Selinexor with Lenalidomide and Lenalidomide alone for patients with newly diagnosed Multiple Myeloma undergoing Autologous stem cell transplant.

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Trial Information

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 increased to 60mg 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

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

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.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australian Leukeamia and Lymphoma Group (ALLG)
Primary Sponsor Address: ALLG 35 Elizabeth St Richmond Victoria 3121
Primary Sponsor Country: Australia

Trial IDACTRN12620000291987

Contact person for information and recruitmentMs
Delaine Smith
ALLG 35 Elizabeth Street Richmond Victoria 3121
+61 3 8373 9701

Further information icondelaine.smith@allg.org.au
Australia

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 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
St George Hospital - Kogarah

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

Postcode
3004 - Melbourne

Postcode
2217 - Kogarah

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

Trial location outside Australia

Country
New Zealand

State
Dunedin Hospital - Southern DHB

Country
New Zealand

State
Middlemore Hospital, Auckland

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

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

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?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
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

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

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 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 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

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