ClinTrial Refer

Trial Acronym
ALLG: MM26/NORM

Registration Number
ACTRN12622001308785P

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

Multiple myeloma is a plasma cell malignancy that remains incurable. In multiple myeloma, patients with non-measurable disease, poor kidney function, extramedullary relapse, or Central nervous system myeloma are frequently excluded from clinical trials. Considering this, none of the available treatments have been adequately studied in these populations, and these patients represent a group with an unmet clinical need. We plan to establish a platform trial to look at these orphan groups (strata) of patients who have previously had no prospect of enrolment in clinical trials and in groups of patients who have not been explored before.

Therefore, this clinical trial aims to assess the effectiveness of different treatment regimens for patients with first or second relapse of Multiple Myeloma. 

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have been diagnosed with Multiple myeloma and have had 1-2 prior lines of treatment. 

Study details
Participants who choose to participate in this trial will undergo screening assessments to see if they meet one of the four following disease criterions described as stratums:
•Stratum A: Poor kidney function, defined by a laboratory value of creatinine clearance (CrCl) less than 30mls per minute.  
•Stratum B: Non-measurable disease (defined by specific levels for blood and urine tests collected at screening)
•Stratum C: presence of a plasma cell tumour that develops outside the bone marrow (extramedullary plasmacytoma) 
•Stratum D: Central Nervous System (CNS) myeloma
Once the participant has met one of the four disease criteria described above, they will be assigned to the corresponding platform clinical trial (called appendixes) based of the four stratums described above. Once it is determined which platform trial they should be assigned to, the participant will be screened and consented again for the platform trial and go on to receive treatment if they meet the eligibility for the specific platform trial. This will continue until the participant experiences either unacceptable toxicity, or disease progression. Participants will be monitored for adverse effects for the duration of treatment, as well as the start of every cycle for assessment of their response to treatment through blood and urine samples and/or bone marrow biopsies, and assessment of quality of life through completion of a questionnaire.

It is hoped this research will determine whether the combination of different treatments in treating a specific population of participants with relapsed or refractory myeloma is successful. If this combination treatment is found to be effective, it may be used to improve the health outcomes of future patients with refractory and relapsed multiple myeloma.

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

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.

Trial Location Name

Address

Status

Princess Alexandra Hospital (Haematology)

199 Ipswich Rd, Woolloongabba QLD 4102, Australia

Closed

Primary Contact : David Barnes, david.barnes2@health.qld.gov.au , +617 3176 6827

Secondary Contact : Steven Ivanhoe, steven.ivanhoe@health.qld.gov.au , (07) 3176 6826

Royal Adelaide Hospital (Haematology)

Port Rd, Adelaide SA 5000, Australia

Recruiting

Primary Contact : Chris Hoare, christine.hoare@sa.gov.au , 08 7074 3290

St Vincents Hospital Sydney (Haematology)

St Vincent's Hospital Sydney, Victoria Street, Darlinghurst NSW, Australia

Recruiting

Primary Contact : Joshua Neish, joshua.neish@svha.org.au , 0478 267 680

Australasian Leukaemia & Lymphoma Group (ALLG)

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12622001308785p

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Not Applicable

Minimum Age
18

Maximum Age
100

Date Registered
02/07/2023

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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