ALLG MM26/NORM: Novel Combinations for Orphan Myeloma: The NORM platform study Master Protocol

Not Applicable

Recruiting

Conditions: relapsed/refractory multiple myeloma
Cancer - Myeloma

Registration Number: ACTRN12622001308785

Lead Sponsor: Australasian Leukaemia & Lymphoma Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

All of the following criteria must be satisfied for enrolment in the trial. The domain specific appendix can refine the inclusion and exclusion criteria in this Master Protocol.

1. Histologically confirmed diagnosis of symptomatic multiple myeloma as per IMWG
2. Relapsed or refractory multiple myeloma with documented evidence of progressive disease (PD) following at least 1 prior line of therapy
3 .Must met one of the following criteria
• Renal impairment, defined as Cockcroft-Gault, CrCl less than 30ml/min (stratum A)
• Non-measurable disease, defined as a paraprotein less than 5g/L on serum EPG/IFE, involved light chain less than 100mg/L and urinary Bence Jones protein less than 200mg/L (stratum B)
• Extramedullary plasmacytoma (stratum C)
• CNS myeloma (stratum D)
4. Has provided written informed consent
5. Available for follow-up for 3 years
6 .Females of childbearing potential must use an effective method of contraception or practice absolute abstinence as required for individual drug combinations (see relevant appendices)
7. Male patients must use contraception measures as required for individual drug combinations (see relevant appendices)
8 .For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
9. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
10. An ECOG performance status score of 2 or less at Screening
11. Subjects must agree not to share their medication and to return unused supplies

Exclusion Criteria

Presence of any of the following criteria will exclude the subject from enrolment in the trial. The domain specific appendix can refine the inclusion and exclusion criteria in this Master Protocol.

1. Women who are pregnant or lactating.
2. Patients who have had investigational anti-cancer therapy, chemotherapy or radiotherapy within 4 weeks of Cycle 1 Day 1
3. Prior diagnosis of cancer that was:
• more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
• within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
4. Documented systemic amyloid light chain amyloidosis
5. Red blood cell or platelet transfusion within 14 days of screening
6. Patients with uncontrolled intercurrent illness, e.g. uncontrolled active hypertension or diabetes.
7. Active, unstable cardiovascular function:
a. Symptomatic ischemia
b. Uncontrolled, clinically-significant conduction abnormalities (patients with ventricular tachycardia on antiarrhythmics are excluded, patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded) or
c. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class greater than or equal to 3, or
d. Myocardial infarction (MI) within 3 months prior to C1D1
e. Ejection fraction (EF) less than 50% at screening
8. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
9. Known HIV infection
10. Patients with psychiatric illness/social situations that would limit compliance with trial requirements.
11. Has any other clinically important abnormalities as determined by the investigator that may interfere with participation in or compliance with the trial.
12. Presence of any psychological, familial or sociological condition potentially hampering compliance with the trial protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.