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RecruitingLast updated: 22 June 2026

ZEPFHR-MM: A trial for people with multiple myeloma that has relapsed after prior treatment to assess the efficacy of different treatment combinationsA Centralized Platform study for Functional High Risk Multiple Myeloma - Master Protocol

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

ZEPFHR-MM

Clinical summary

Summary

Patients who have functional high-risk disease currently do not have optimal treatments available via the Pharmaceutical Benefits Scheme and have poorer outcomes compared to myeloma patients who are not considered functional high-risk.

You may be eligible for this study if you have a diagnosis of multiple myeloma and have relapsed within 18 months following initiation of first-line therapy and require further treatment. 

This is a platform study that has been designed to make the process of testing different treatments for the same disease more efficient by making these treatments under one "platform", and therefore under one ethics approval. 

Within the platform, there are different "domains", similar to treatment arms. Your treating doctor will decide which domain is potentially suitable for you. 

Biological samples, such as blood and bone marrow, will be collected to assess how you respond to treatment. These samples will also be used for scientific research to better understand how myeloma changes after using these treatments.

It is hoped that findings from this study will provide information on newer treatments that are not yet available in Australia to treat functional high-risk melanoma.

Conditions

This trial is treating people with multiple myeloma

Eligibility

Inclusion

- Age >= 18 years of age.
- Able to provide written consent.
- Documented diagnosis of MM with measurable disease as define by any of the following
- Serum M-component greater than 5 g per L and/or
- Urine M-component greater than200 mg per 24 h, and/or
- Involved serum free light chain level greater than 100mg per L.
- Patients who do not meet these criteria but have biopsy proven extra-medullary disease (extra-osseous plasmacytoma that is not contiguous with an osseous plasmacytoma) that can undergo response evaluation with serial PET-CT are considered to have measurable disease.
- Documented evidence of progressive disease within 18 months of commencing front-line therapy for newly diagnosed MM according to IMWG response criteria
- Patients must have received only 1 prior therapy consisting of an IMID or PI-based induction regimen with or without high dose melphalan conditioned autologous stem cell transplant +/- lenalidomide maintenance.
- No contraindication to the use of any of the study drugs and able to comply with trial requirements.
Adequate liver function (total bilirubin less than 2.0x upper limit of normal (ULN), alanine aminotransferase less than 5.0x ULN) unless considered secondary to MM.
- Absolute neutrophil count greater than or equal to 1.0 x 109 per L. Granulocyte colony-stimulating factor (G-CSF) therapy is permitted on study.
Platelet count greater than or equal to 50 x 109/L (greater than or equal to 30 x 109 per L if MM involvement in the marrow is greater than 50 per cent), patients should not have received platelet transfusions within 7 days of the screening platelet count.
- Hb greater than or equal to 80g per L, red cell transfusions as per institutional protocol are allowed.
- Has provided written informed consent.
- Women of childbearing potential participants must not become pregnant while on study; male participants must not father children while on study

Exclusion

- 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.
- 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.
- Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency virus positivity. Patients with latent TB can proceed on study provided adequate prophylaxis has been commenced.
- Known autoimmune disease requiring ongoing immunosuppression
- Women who are pregnant or lactating. Women of child-bearing potential must have a negative pregnancy test (minimum sensitivity of at least 25 mIU per mL) at Screening.
- 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 greater than 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 greater than 2 years.
- 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.
- Participation in other clinical trials for the treatment of MM, 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Australasian Myeloma Research Consortium

Scientific Title

A Centralized Platform study for Functional High Risk Multiple Myeloma - Master Protocol

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