Trial summary

This is a study to characterise the effects of a Moderate CYP3A4 and P-glycoprotein Inhibitor on the impact of Bomedemstat (IMG-7289) in healthy volunteers. IMG-7289 may be indicated for use in patients with cancer. A drug-drug interaction trial is needed to better understand how the body interacts with administered drugs throughout the entire duration of drug exposure. 

Who is it for?

You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study.

Study details

This trial will take place over 73 days, where participants will be screened for 28 days, receive oral medication over a 13-day period, and will then be followed up. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing.

It is hoped this research will determine whether Moderate CYP3A4 and P-glycoprotein Inhibitor have an effect on the reaction of volunteers to Bomedemstat (IMG-7289). Healthy participants in the current study will not receive any health benefit (beyond that of an assessment of their medical status) from participating in the study; however, data from this study will support the potential development of bomedemstat.

Broad Health ConditionCancer

Specific Health ConditionCancer
Myeloma
Blood
Haematological diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
CMAX Clinical Research Pty Ltd - Adelaide

Postcode
5000 - Adelaide

Anticipated date of last participant enrolment4/10/2023

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Must have given written informed consent before any study related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2.	Adult males and females, 18 to 65 years of age (inclusive) at Screening Visit.
3.	Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2, with a body weight greater than or equal to 55 and less than or equal to 100 kg at Screening Visit.
4.	Be non-smokers (including tobacco, e-cigarettes or other nicotine containing products, and marijuana) for at least 1 month prior to first study drug administration and have a negative result of cotinine test at screening and on Day -1. In the event the cotinine test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility.
5.	No prior history of chronic alcohol abuse or excessive alcohol intake, at the discretion of the PI, within 12 weeks prior to screening. No alcohol is to be consumed for at least 48 hours prior to admission, with negative alcohol test results (at screening and on Day -1). In the event the alcohol breath test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility. Excessive alcohol intake is defined as regular consumption of >12 standard units of alcohol per week, or more than 4 standard drinks on >3 days per week, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]).
6.	No prior history of substance abuse or drug addiction within 12 months prior to first study drug administration and negative urine drug screen results at screening and on Day -1. In the event the urinary drug test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility.
7.	No prior history of relevant drug hypersensitivity.
8.	Medically healthy (in the opinion of the PI) as determined by pre-study medical history and without CS abnormalities at screening, and after check-in on Day -1, and prior to first dose administration on Day 1, including:
a.	Physical examination without any clinically relevant findings;
b.	Systolic blood pressure in the range of 100 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in supine position;
c.	Pulse rate (PR) in the range of 50 to 100 beats/minute after 5 minutes rest in supine position;
d.	Body temperature (tympanic), between 35.5°C and 37.7°C;
e.	A 12-lead ECG within normal range (QTcF males less than or equal to 450 ms; QTcF females less than or equal to 470 ms) or with abnormalities that are not hazardous to the participant according to the opinion of the PI;
f.	No clinically relevant findings in clinical laboratory blood and urinalysis tests as judged by the PI; 
g.	ALT/AST  less than or equal to 1.5 ULN, total bilirubin  less than or equal to 1.5 x ULN and/or creatinine clearance greater than or equal to 80mL/min (calculated using Cockcroft & Gault formula).
NOTE: Laboratory results obtained during screening and prior to first dose administration on Day 1 should be used to determine eligibility criteria. In situations where laboratory results, vitals or ECGs are outside the permitted range, the Investigator may retest the participant once and the subsequent within range screening result may be used to determine the participant’s eligibility.
9.	Participants with a history of Hepatitis B or C are eligible on the condition that participants have adequate liver function as defined by Inclusion Criterion #8 and are hepatitis B surface antigen (HBsAg) negative and/or have undetectable hepatitis C virus (HCV) RNA.
10.	Female participants must:  
a.	Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 months prior to dosing) or post-menopausal (where post-menopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level >40 IU/L at the Screening Visit), or
b.	If of child-bearing potential, must have a negative serum pregnancy test at screening and before the first study drug administration (Day -1, urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study drug. 
c.	Must not be breast-feeding.
11.	Male participants, if not surgically sterilised, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study drug. Note that oral, injected or implanted hormonal methods of contraception must be established in the female partner who could become pregnant, and in use for at least a month prior to screening.
12.	Have suitable venous access for blood sampling.
13.	Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1.	Is pregnant or nursing.
2.	Has an active or prior malignancy. 
Exception: Participants who has been disease-free for 1 year, or a participant with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
3.	Has thrombocytopenia, neutropenia, or anaemia, i.e., not within the normal range based on local lab references with a single repeat and minor aberrations allowable at the discretion of the PI, and any prior history of myeloid malignancies, including MDS. 
4.	Has had major surgery (in the opinion of the Investigator) within 3 months prior to enrollment.
5.	Is unwilling to exclude grapefruit, grapefruit juice or products that contain grapefruit, star fruit, pomegranate, pomelo, tangelo or Seville orange-containing products from the diet and all foods that contain those fruits from time of enrolment until discharge from the clinical unit.
6.	Has cardiovascular impairment, history of congestive heart failure greater than New York Heart Association Class II, arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the planned first dose of bomedemstat; or ventricular cardiac arrhythmia requiring medical treatment.
7.	Participants taking medications that are known potent or moderate inducers or inhibitors of CYP3A4 (including St. John’s Wort).
8.	Blood or plasma donation of >100 mL during the 4 weeks prior to Day -1.
9.	Participation in another clinical trial of an investigational molecule (or medical device) within 30 days (or 5 half-lives of the drug, whichever is longer) prior to the start of IP administration on Day 1 (or within 6 months or 5 half-lives, whichever is longer, prior to the start of IP administration on Day 1 if the investigational drug was an immunosuppressive biologic). 
10.	Received treatment with immune-suppressive or immune-modulative medication (including topical, systemic and inhalant corticosteroids) or have received immunoglobulins and/or blood products within 4 months prior to the administration of the first dose of IP.
11.	Exposure to any prescription medications (small molecules), topically or systemically administered over-the-counter drugs, dietary supplements, or herbal remedies (with the exception of aspirin) within 14 days or 5 half-lives (if known), (whichever is longer) prior to the start of IP administration on Day 1.
12.	Has an active infection or recent history (<30 days before study drug administration) requiring systemic treatment. 
13.	Is immunocompromised (in the opinion of the Investigator), including participants with known HIV infection.
14.	Has known hypersensitivity to any of the components of the IP.
15.	Is unable to take oral medications, has a history of surgery that in the opinion of the PI would interfere with the administration or absorption of oral medication, has malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhoea or vomiting) that might impair the bioavailability of IP.
16.	Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness that would limit compliance with study requirements. At discretion of the PI, participants with any history of depression or suicidal ideation will be excluded and at a minimum, participants with a prior history should have stable mental state off medications for >6 months.
17.	A history of bleeding (i.e., hemoptysis, hematuria, gastrointestinal blood loss, epistaxis, or others with greater than Grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5.0) within 1 month prior to beginning therapy or any clinical indications of current active bleeding.
18.	Individuals who have smoked cigarettes or tobacco within the 1 month prior to first study drug administration or have a positive urine cotinine result at Screening or Day -1.
19.	Any other condition, which in the opinion of the PI precludes the participant’s participation in the clinical study.
 

Trial summary

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

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

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

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

Broad Health ConditionHaematological malignancy
Immunosuppression
COVID-19

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

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Hospital
Perth Blood Institute - West Perth

Postcode
6005 - West Perth

Anticipated date of last participant enrolment1/09/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

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

Trial summary

Australian data shows that 20-25% of newly diagnosed myeloma patients who are treated with standard of care relapse within the first 12 months of starting treatment and their survival rate is lower than that of patients who relapse after 12 months of starting treatment. This group of patients are deemed to be at ‘high-risk’. The purpose of this study is to optimise treatment of newly diagnosed multiple myeloma (MM) patients who undergo autologous stem cell treatment (ASCT) by using diagnostic techniques to guide whether selinexor should be added to standard care, whether it is and beneficial to do so.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have been recently diagnosed with multiple myeloma. If must meet additional heart, liver and kidney health criteria prior to commencing treatment.

[Study details]
All participants who choose to enrol in this study will have a bone marrow sample taken and assessed to determine whether they are at high risk or standard risk disease. These details will then be used to allocate participants for ‘induction’ therapy, to either standard of care treatment (consisting of bortezomib, lenalidomide and dexamethasone), or standard of care treatment with added selinexor. This is a risk-adaptive approach to treatment, meaning your treatment is guided by the results of your myeloma risk profile. Participants will continue with their allocated treatments for 4-5 months. After this time, all participants will then undergo preparation for an autologous stem cell transplant, where healthy stem cells will be harvested from each participant and expanded externally, before being re-implanted back to stimulate further stem cell growth. At 5-6 months after the transplant, all participants will be required to provide a second bone marrow sample to undergo a second test to check how they are responding to treatment and assess if there is a very small but detectable number of myeloma cells. For standard risk patients, if there isn’t any detectable myeloma cells, you will continue treatment with only lenalidomide. If there are detectable cells, you will be given lenalidomide and selinexor. High-risk patients will be given lenalidomide and selinexor regardless of the results. This is called 'maintenance' therapy. Participants will then continue taking their second allocation of medications for maintenance for until the treatments are no longer effective. This could range from months to years. Further bone marrow samples will be required at 6 and 12 months after commencing maintenance treatment to test for detectable myeloma cells. The trial is intended to run over 4-5 years. You will be asked to complete short questionnaires about your multiple myeloma treatment and your health-related quality of life every month prior to the transplant, about 4-5 months after transplant and within 12 months after commencing maintenance therapy. 

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
The Alfred - Melbourne

Hospital
Nepean Hospital - Kingswood

Postcode
3004 - Melbourne

Postcode
2747 - Kingswood

Anticipated date of first participant enrolment1/05/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Male and Female patients,  18 years of age or older
2.	Able to provide written consent.
3.	Newly diagnosed MM as per IMWG criteria eligible for ASCT.
4.	Diagnostic bone marrow sample available for SKY92 risk analysis.
5.	Measurable disease as defined by any of the following
o	Serum M-component >5 g/L, and/or
o	Urine M-component > 200 mg/24 h, and/or
o	Involved serum FLC level >100mg/L.
6.	No contraindication to the use of any of the study drugs and able to comply with trial requirements.
7.	Adequate liver function (total bilirubin < 2.0x ULN, ALT < 5.0x ULN) unless considered secondary to MM.
8.	Absolute neutrophil count >= 1.0 x 109/L.
9.	Platelet count >= 50 x 109/L (>= 30 x 109/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
10.	Hb >= 80g/L, red cell transfusions as per institutional protocol are allowed.
11.	Woman of childbearing potential must agree to ongoing pregnancy testing, to be performed within 72 hours before during treatment and on day 28 after last dose of study treatment.
12.	Women of childbearing potential must agree to use one highly effective method and preferably one additional effective (barrier) method during the study and for 28 days following the last dose of study treatment.
13.	Male participants who are sexually active with WOCBP must use a condom during sexual contact during study and for at least 7 days after last dose of study treatment.
14.	Male participants must not donate sperm during study and for at least 7 days after last dose of study treatment.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Patients who have had myocardial infarction within 6 months prior to enrolment, or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
2.	Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators’ opinion, potentially interfere with the completion of treatment according to this protocol.
3.	Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency positivity.
4.	Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
5.	Any patient who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention programme.
6.	Active malignancy with the exception of any of the following: 
o	Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
o	Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
o	Stage 1 prostate cancer that does not require treatment.
o	Any other cancer from which the subject has been disease-free for > 2 years.
7.	Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.

Trial summary

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

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

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

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

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

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

Broad Health ConditionInfluenza vaccination
Haematological malignancy

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

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Postcode
3000 - Melbourne

Postcode
3084 - Heidelberg

Anticipated date of first participant enrolment1/04/2022

Anticipated date of last participant enrolment31/10/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Male and female subjects aged greater than or equal to 18 years and currently receiving or have received within last 12 months treatment for MM, CLL and NHL. Women of child-bearing potential will need to be on adequate contraception. 
2.	Willing and able to provide a blood sample just prior to vaccination, 21-28 days post each dose and roughly 6 months post-vaccination.
3.	Has not received influenza vaccine for the 2022 season 
4.	No known contraindications for influenza vaccination.
5.	Willing to provide current mobile phone number for SMS reminders

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Known contraindication(s) for QIV (e.g. hypersensitivity to vaccine component (including eggs)).
2.	Recent stem cell transplant (less than 12 months)
3.	Hypogammaglobulinaemia on immunoglobulin replacement
4.	Recently (within last 7 days) unwell with a fever above 38°C. 
5.     Prior participation in the study (i.e. during the 2022 enrolment year)

Trial summary

The aim of the study is to find out if oral antibiotics can be used instead of immunoglobulin (Ig) for preventing infections in patients with blood cancers, and if the oral antibiotics should be taken every day or only once symptoms of infection occur.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have received Ig treatment for over 6 months.

Study details
Participants will be randomised (allocated by chance) to one of three treatment groups, as follows:
- stop Ig, and be given oral antiobiotics (such as co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg) to take every day
- stop Ig, and be given oral antibiotics (amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg) to keep at home, and used only if infection symptoms occur
- continue receiving their usual Ig treatment
The duration of each treatment is for 12 months.

Over the course of the 13 month study participation period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period.

Types of assessments and data collected will include: medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.

It is hoped that this study will confirm if Ig used to prevent infections can be safely stopped, and if oral antibiotics should be given as an alternative, thus improving treatment for people with blood cancer.

Broad Health Conditionhaematological malignancy
hypogammaglobulinemia

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

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,VIC

Hospital
The Alfred - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
The Canberra Hospital - Garran

Hospital
Concord Repatriation Hospital - Concord

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Western Hospital - Footscray - Footscray

Postcode
3004 - Melbourne

Postcode
3084 - Heidelberg

Postcode
2605 - Garran

Postcode
2139 - Concord

Postcode
3168 - Clayton

Postcode
2065 - St Leonards

Postcode
3011 - Footscray

Trial location outside Australia

Country
New Zealand

State
Wellington

Country
New Zealand

State
Waikato

Anticipated date of first participant enrolment31/05/2022

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Approved

Key inclusion criteria

1. Aged greater than or equal to 18 years of age
2. Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL). 
3. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months. 
4. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator. 
5. Life expectancy greater than 12 months. 
6. Able to give informed consent, and willing and able to comply with each of the treatment arms. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Prior or planned allogeneic haematopoietic stem cell transplantation. 
2. Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring antimicrobial treatment. 
3. Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and PJP prophylaxis). 
4. Intolerance of all trial antibiotic options in either arm A or arm B.
5. Communication, compliance or logistical issues that are likely to limit patient’s ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.
6. Pregnant or breastfeeding.
7. Severe renal impairment (estimated or measured creatinine clearance of less than 30 mL/min).
8. Previous splenectomy.
9. Previous participation in this trial.
10. Treating team deems enrolment in the study is not in the best interests of the patient. 

Trial summary

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

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

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

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

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

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

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

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
Peter MacCallum Cancer Centre - Melbourne

Postcode
3050 - Parkville

Postcode
3000 - Melbourne

Anticipated date of first participant enrolment28/02/2022

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

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

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

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

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

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

Broad Health ConditionMyeloma
Lekaemia
Lymphoma
Lung Cancer
Melanoma

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

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

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

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

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

Broad Health ConditionHaematological Malignancy
Bone Marrow Transplant
COVID-19

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

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of last participant enrolment6/04/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

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

Trial summary

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

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

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

Broad Health ConditionMyeloma

Specific Health ConditionCancer
Myeloma

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Anticipated date of last participant enrolment28/12/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

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

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

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

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

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

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne

Postcode
3000 - Melbourne

Anticipated date of last participant enrolment1/06/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

Broad Health ConditionAutologous Stem Cell Transplant

Specific Health ConditionCancer
Myeloma
Public Health
Health service research

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Nepean Hospital - Kingswood

Postcode
2747 - Kingswood

Anticipated date of last participant enrolment1/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Not fit for Autologous stem cell transplant
Unwilling to participate

Trial summary

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

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

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

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

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

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

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,VIC

Hospital
The Alfred - Melbourne

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

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Concord Repatriation Hospital - Concord

Hospital
Border Medical Oncology - Albury

Hospital
Flinders Medical Centre - Bedford Park

Hospital
The Townsville Hospital - Douglas

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
3004 - Melbourne

Postcode
3065 - Fitzroy

Postcode
3220 - Geelong

Postcode
5000 - Adelaide

Postcode
2298 - Waratah

Postcode
2139 - Concord

Postcode
2640 - Albury

Postcode
5042 - Bedford Park

Postcode
4814 - Douglas

Postcode
4029 - Herston

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment31/12/2020

Anticipated date of last participant enrolment31/12/2023

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Participants must have: 
1. Male or female, 18 years or older, capable of giving consent.
2. Have confirmed MM as defined by IMWG criteria.
3. ECOG Performance Status 0-2.
4. Have had at least 1 and no more than 3 prior lines of therapy.
5. Must have measurable disease defined as at least one of:
o Serum M-protein concentration of greater than or equal to 5g/L
o Urine M-protein excretion greater than or equal to 200mg/24hr or
o Serum free light chain (FLC) assay: involved FLC level greater than or equal to 100mg/L and an abnormal serum free light chain ration (less than 0.26 or greater than 1.65)
6. Adequate organ system function:
o Haematological (transfusion and/or growth factor support within 2 weeks are not permitted for the purpose of meeting eligibility criteria): 
- Absolute neutrophil  greater than or equal to 1.0x10^9/L
- Haemoglobin  greater than or equal to 80g/L
- Platelet  greater than or equal to 50x10^9/L
o Hepatic:
- ALT less than 2.5xULN
- Bilirubin unless than 1.5xULN (Isolated bilirubin greater than or equal to 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%)
o Renal:
- eGFR greater than 30ml/min
- Spot urine (albumin/creatinine ratios) less than 500 mg/g (56 mg/mmol)
o Cardiac:
- LVEF greater than 45%
7. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 
- Is not a woman of childbearing potential (WOCBP)
OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of  less than 1% per year), preferably with low user dependency (as described in Appendix 6), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. 

The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
Non-childbearing potential is defined as follows (by other than medical reasons):
- greater than or equal to 45 years of age and has not had menses for greater than 1 year.
- Patients who have been amenorrhoeic for  less than 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.
? - Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
8. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.  
Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:
- Refrain from donating sperm.
PLUS either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
- Must agree to use contraception/barrier as detailed below:
Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of  less than 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).
9. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be equal to Grade 1 at the time of enrolment except for alopecia.
10. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants must not have had/be:
1. Systemic anti-myeloma therapy within ?14 days with the exception of corticosteroids equivalent to dexamethasone ?160mg in total within last 4 weeks.
2. Prior treatment with mAb (except for mAb for COVID-19 prophylaxis or management) within 30 days of receiving first dose of study drugs
3. Evidence of cardiovascular risk: 
- Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block; Clinically significant, uncontrolled arrhythmias
- History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, or stenting or bypass grafting within last 6 months; 
- Class III or IV heart failure defined by New York Heart Association functional classification system.
- Uncontrolled hypertension
4. Pregnant or lactating females.
5. Active infection requiring treatment.
6. Known HIV infection.
7. Active Hepatitis B infection. Patients with positive HBcAB and negative HBsAg are eligible provided HBV DNA is negative.  
8. Positive hepatitis C antibody and positive hepatitis C RNA at screening or within 3 months prior to first dose of study treatment. (NOTE: participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if confirmatory negative hepatitis C RNA is obtained.).
9. Current corneal epithelial disease except for mild changes in corneal epithelium
10. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin..
11. Ongoing grade 2 or higher peripheral neuropathy.
12. Known immediate or delayed hypersensitivity reaction to proteasome inhibitors, or unacceptable adverse effects from previous proteasome inhibitors. 
13. Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis.  Note: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
14. Participant must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant’s safety).  Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria.
15. Participant must not use contact lenses while participating in this study.
16. Participant must not be simultaneously enrolled in any interventional clinical trial.
17. Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
18. Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment.
19. Participant must not have had major surgery = 4 weeks prior to initiating study treatment.
20. Participant must not have any evidence of active mucosal or internal bleeding.
21. Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
22. Participant must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant’s safety, obtaining informed consent or compliance to the study procedures.

Trial summary

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

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

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

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

Broad Health ConditionHaematological malignancy

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

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Cabrini Hospital - Malvern - Malvern

Postcode
3144 - Malvern

Anticipated date of first participant enrolment9/03/2020

Anticipated date of last participant enrolment1/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

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

Minimum age16 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

Who is it for?

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

Study details

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

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

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

Patients will receive treatment until disease progression.

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

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

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

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

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

Hospital
The Alfred - Melbourne

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Townsville University Hospital - Douglas

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Concord Repatriation Hospital - Concord

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Border Medical Oncology - Albury

Hospital
Fiona Stanley Hospital - Murdoch

Hospital
Lismore Base Hospital - Lismore

Hospital
Orange Health Service - Orange

Hospital
Launceston General Hospital - Launceston

Hospital
Western Hospital - Footscray - Footscray

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Royal Hobart Hospital - Hobart

Postcode
3065 - Fitzroy

Postcode
3004 - Melbourne

Postcode
3084 - Heidelberg

Postcode
3220 - Geelong

Postcode
4102 - Woolloongabba

Postcode
4814 - Douglas

Postcode
3168 - Clayton

Postcode
2139 - Concord

Postcode
3000 - Melbourne

Postcode
2640 - Albury

Postcode
6150 - Murdoch

Postcode
2480 - Lismore

Postcode
2800 - Orange

Postcode
7250 - Launceston

Postcode
3011 - Footscray

Postcode
5000 - Adelaide

Postcode
2010 - Darlinghurst

Postcode
7000 - Hobart

Trial location outside Australia

Country
New Zealand

Anticipated date of first participant enrolment3/08/2020

Anticipated date of last participant enrolment18/01/2024

Phase of TrialPhase 3

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

• Pregnant or lactating women.
• Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the 
   reversible effects of prior chemotherapy.
• Progressive disease post-ASCT.
• Major surgery within 14 days before enrolment.
• Radiotherapy within 14 days before enrolment. If the involved field is small, 7 days will be 
   considered a sufficient interval between treatment and administration of the selinexor.
• Central nervous system involvement.
• Active infection requiring iv antibiotics in 5 days prior to starting study therapy.
• Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B 
  has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial 
  treatment. Subjects with untreated hepatitis C virus (HCV) are not allowed. Subjects with 
  Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts greater than or equal 
  to 350 cells/µL and no history of AIDS-defining opportunistic infections in the last year are 
  allowed.
• Any serious medical or psychiatric condition (including uncontrolled infection) that could, 
  in the investigator’s opinion, potentially interfere with the completion of treatment 
  according to this protocol or would be a contraindication to consolidation/maintenance 
  therapy.
• Known allergy to any of the study medications, their analogues, or excipients in the 
   various formulations of any agent.
• Known GI disease or GI procedure that could interfere with the oral absorption or 
   tolerance of study medications including difficulty swallowing.
• Patient has greater than or equal to 2 grade peripheral neuropathy or grade 1 with pain on 
   clinical examination during the screening period.
• Participating in other clinical trials, including those with other investigational agents not 
   included in this trial, within 30 days of the start of this trial and throughout the duration of 
   this trial.
• Contraindication to the use of either lenalidomide or selinexor.

Trial summary

The study utilises the infrastructure of a national clinical registry (Australian and New Zealand Myeloma and Related Diseases Registry) to enable identification of patients, efficient data collection, long-term follow-up beyond the trial and comparison with non-trial patients to assess study generalisability. The primary purpose of this trial is to assess appropriate treatment approach newly diagnosed with multiple myeloma with respect to frailty assessment.

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

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

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

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

Hospital
The Alfred - Melbourne

Hospital
Calvary Mater Newcastle - Waratah

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Royal Hobart Hospital - Hobart

Hospital
Sunshine Hospital - St Albans

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Sunshine Coast University Hospital - Birtinya

Hospital
Concord Repatriation Hospital - Concord

Hospital
Tamworth Rural Referral Hospital - Tamworth

Hospital
Western Hospital - Footscray - Footscray

Hospital
Nepean Hospital - Kingswood

Hospital
Royal Darwin Hospital - Tiwi

Hospital
The Townsville Hospital - Douglas

Hospital
The Queen Elizabeth Hospital - Woodville

Hospital
Toowoomba Hospital - Toowoomba

Hospital
The Northern Hospital - Epping

Hospital
Latrobe Regional Hospital - Traralgon

Postcode
3004 - Melbourne

Postcode
2298 - Waratah

Postcode
5000 - Adelaide

Postcode
7000 - Hobart

Postcode
3021 - St Albans

Postcode
4102 - Woolloongabba

Postcode
4575 - Birtinya

Postcode
2139 - Concord

Postcode
2340 - Tamworth

Postcode
3011 - Footscray

Postcode
2747 - Kingswood

Postcode
0810 - Tiwi

Postcode
4814 - Douglas

Postcode
5011 - Woodville

Postcode
4350 - Toowoomba

Postcode
3076 - Epping

Postcode
3844 - Traralgon

Trial location outside Australia

Country
New Zealand

State
Dunedin Hospital - Southern DHB

Country
New Zealand

State
Middlemore Hospital, Auckland

Country
New Zealand

State
North Shore Hospital, Auckland

Country
New Zealand

State
Christchurch Hospital

Anticipated date of first participant enrolment15/11/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Approved

Key inclusion criteria

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

2.	Symptomatic NDMM as per IMWG criteria

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

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

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

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

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

8.	Has provided written informed consent.

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

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

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

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

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

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

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

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

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

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

Trial summary

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

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

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

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

Broad Health ConditionMultiple myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Greenslopes Private Hospital - Greenslopes

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
North Lakes Health Precinct - North Lakes

Postcode
4120 - Greenslopes

Postcode
4102 - Woolloongabba

Postcode
4029 - Herston

Postcode
4509 - North Lakes

Anticipated date of first participant enrolment18/03/2019

Anticipated date of last participant enrolment31/12/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

Who is it for?

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

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

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,TAS,WA,VIC

Hospital
The Alfred - Prahran

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

Hospital
Epworth Freemasons (Clarendon Street) - East Melbourne

Hospital
Royal Hobart Hospital - Hobart

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Fiona Stanley Hospital - Murdoch

Hospital
St George Hospital - Kogarah

Hospital
Border Medical Oncology - Albury

Hospital
Concord Repatriation Hospital - Concord

Hospital
Calvary Mater Newcastle - Waratah

Postcode
3004 - Prahran

Postcode
3065 - Fitzroy

Postcode
3002 - East Melbourne

Postcode
7000 - Hobart

Postcode
5042 - Bedford Park

Postcode
6150 - Murdoch

Postcode
2217 - Kogarah

Postcode
2640 - Albury

Postcode
2139 - Concord

Postcode
2298 - Waratah

Anticipated date of first participant enrolment25/03/2019

Anticipated date of last participant enrolment31/03/2023

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

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

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

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

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

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

Recruitment statusRecruiting

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

Hospital
The Alfred - Prahran

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Prince Alfred Hospital - Camperdown

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
The Northern Hospital - Epping

Hospital
St George Hospital - Kogarah

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
Cabrini Hospital - Malvern - Malvern

Hospital
The Canberra Hospital - Garran

Hospital
Box Hill Hospital - Box Hill

Hospital
Royal Hobart Hospital - Hobart

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Latrobe Regional Hospital - Traralgon

Hospital
Concord Repatriation Hospital - Concord

Hospital
Icon Cancer Care South Brisbane - South Brisbane

Hospital
Icon Cancer Care Chermside - Chermside

Hospital
Icon Cancer Care Southport - Southport

Hospital
Icon Cancer Care Wesley - Auchenflower

Hospital
Epworth Freemasons - Melbourne

Hospital
Hollywood Private Hospital - Nedlands

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Lismore Base Hospital - Lismore

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
Frankston Hospital - Frankston

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

Hospital
Liverpool Hospital - Liverpool

Hospital
Sunshine Hospital - St Albans

Hospital
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Bairnsdale Regional Health Service - Bairnsdale

Hospital
Ballarat Health Services (Base Hospital) - Ballarat Central

Hospital
Border Medical Oncology - Albury

Hospital
Calvary Mater Newcastle - Waratah

Hospital
St John of God Hospital, Geelong - Geelong

Hospital
Central Gippsland Health Service (Sale) - Sale

Hospital
Launceston General Hospital - Launceston

Hospital
Nepean Hospital - Kingswood

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Sunshine Coast University Hospital - Birtinya

Hospital
Toowoomba Hospital - Toowoomba

Hospital
Townsville University Hospital - Douglas

Hospital
Fiona Stanley Hospital - Murdoch

Postcode
3004 - Prahran

Postcode
3084 - Heidelberg

Postcode
4102 - Woolloongabba

Postcode
2050 - Camperdown

Postcode
6009 - Nedlands

Postcode
3076 - Epping

Postcode
2217 - Kogarah

Postcode
3000 - Melbourne

Postcode
3168 - Clayton

Postcode
3144 - Malvern

Postcode
2605 - Garran

Postcode
3128 - Box Hill

Postcode
7000 - Hobart

Postcode
5042 - Bedford Park

Postcode
3844 - Traralgon

Postcode
2139 - Concord

Postcode
4101 - South Brisbane

Postcode
4032 - Chermside

Postcode
4215 - Southport

Postcode
4066 - Auchenflower

Postcode
3002 - Melbourne

Postcode
4029 - Herston

Postcode
2480 - Lismore

Postcode
3220 - Geelong

Postcode
3199 - Frankston

Postcode
3065 - Fitzroy

Postcode
2170 - Liverpool

Postcode
3021 - St Albans

Postcode
5037 - Kurralta Park

Postcode
2065 - St Leonards

Postcode
3875 - Bairnsdale

Postcode
3350 - Ballarat Central

Postcode
2640 - Albury

Postcode
2298 - Waratah

Postcode
3220 - Geelong

Postcode
3850 - Sale

Postcode
7250 - Launceston

Postcode
2747 - Kingswood

Postcode
2010 - Darlinghurst

Postcode
4575 - Birtinya

Postcode
4350 - Toowoomba

Postcode
4814 - Douglas

Postcode
6150 - Murdoch

Trial location outside Australia

Country
Korea, Republic Of

Country
Singapore

Country
Taiwan, Province Of China

Country
New Zealand

Country
Malaysia

Country
China

Anticipated date of last participant enrolment31/12/2040

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

People who decline to participate in the registry. 

Trial summary

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

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

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

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

Broad Health ConditionMultiple Myeloma

Specific Health ConditionCancer
Myeloma

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment8/05/2017

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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

Trial summary

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

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

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

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

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

Broad Health ConditionAL amyloidosis with cardiac involvement

Specific Health ConditionCancer
Myeloma
Cardiovascular
Other cardiovascular diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

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

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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