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RecruitingLast updated: 14 May 2024

MagnetisMM-6: This study aims to determine the optimal dose level and safety of a combination of drugs, and compare its effectiveness to another combination treatment, in people with multiple myelomaAN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA

Clinical summary

Summary

There are two parts to this study.

Part 1 aims to determine how safe and tolerable elranatamab is when administered in combination with daratumumab and lenalidomide, as well as identify the optimal dose(s) of the combination regimen.

Part 2 will evalaute the effectiveness of the combination of elranatamab, daratumumab and lenalidomide compared with the combination of daratumumab, lenalidmode and dexamethasone in peple with newly diagnosed transplant-ineligible multiple myeloma.

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

MagnetisMM-6

More information

Trial Identifiers

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Trial sponsor

Pfizer

Scientific Title

AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA

Eligibility

Inclusion

  • Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)

  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:

    • Serum M-protein ≥0.5 g/dL;
    • Urinary M-protein excretion ≥200 mg/24 hours;
    • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
  • Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant
  • ECOG performance status ≤2.
  • Not pregnant and willing to use contraception
  • For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

Exclusion

  • Smoldering Multiple Myeloma.
  • Monoclonal gammopathy of undetermined significance.
  • Waldenströms Macroglobulinemia
  • Plasma cell leukemia.
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
  • For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
  • For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention).
  • Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
  • Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.

Inclusion

  • You have had treatment, but your cancer has come back.
  • You have been diagnosed with cancer, but have not received any treatment.
  • 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.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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