MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (MAGNETISMM-5)

  • STATUS
    Recruiting
  • End date
    Jan 26, 2026
  • participants needed
    581
  • sponsor
    Pfizer
Updated on 14 May 2022
measurable disease
dexamethasone
lenalidomide
refractory multiple myeloma

Summary

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in both parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Details
Condition Multiple Myeloma
Treatment Pomalidomide, Dexamethasone, Daratumumab, Elranatamab
Clinical Study IdentifierNCT05020236
SponsorPfizer
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Prior diagnosis of multiple myeloma 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
Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
Prior anti-multiple myeloma therapy including treatment with lenalidomide and a
proteasome inhibitor
ECOG performance status ≤2
Not pregnant and willing to use contraception
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

Exclusion Criteria

Smoldering multiple myeloma
Plasma cell leukemia
POEMS Syndrome
Amyloidosis
Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease
Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Previous treatment with a BCMA-directed therapy
Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study
Live attenuated vaccine within 4 weeks of the first dose of study intervention
Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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