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Closed (no longer recruiting)Last updated: 7 February 2024

MAGNETISMM-3: This Phase II trial is trying to understand the benefits of taking a targeted therapy (Elranatamab) alone in people with relapsed or refractory multiple myelomaAN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

Clinical summary

Summary

This is a non-randomised trial assessing the clinical benefits of Elranatamab in people with Multiple Myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody. The trial has two cohorts, both will receive the BCMA-CD3 bispecific antibody Elranatamab (PF-06863135).

Conditions

This trial is treating patients with multiple myeloma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

MAGNETISMM-3

More information

Trial Identifiers

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Trial sponsor

Pfizer

Scientific Title

AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

Eligibility

Inclusion

  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
  • Measurable disease, as defined by at least 1 of the following:

    1. Serum M-protein >0.5 g/dL by SPEP
    2. Urinary M-protein excretion >200 mg/24 hours by UPEP
    3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  • Refractory to at least one IMiD
  • Refractory to at least one PI
  • Refractory to at least one anti-CD38 antibody
  • Relapsed/refractory to last anti-myeloma regimen
  • Cohort A: has not received prior BCMA-directed therapy
  • Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
  • ECOG performance status ≤2
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
  • Not pregnant and willing to use contraception

Exclusion

  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • Amyloidosis
  • POEMS syndrome
  • Stem cell transplant within 12 weeks prior to enrollment
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

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.
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Clinical trials have complex eligibility criteria.

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