MagnetisMM-9: Study of Elranatamab (PF-06863135) Monotherapy in Participants With Relapsed/Refractory Multiple Myeloma MAGNETISMM-9

What's the purpose of this trial?

The purpose of this study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in patients with relapsed/refractory multiple myeloma. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those patients.

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
  • Measurable disease, as defined by at least 1 of the following:
    • Serum M-protein >0.5 g/dL by SPEP
    • Urinary M-protein excretion >200 mg/24 hours by UPEP
    • 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
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • POEMS syndrome
  • Amyloidosis
  • Stem cell transplant within 12 weeks prior to enrollment or active GVHD
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
  • Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
  • Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
  • History of any grade peripheral sensory or motor neuropathy with prior BCMA-directed therapy.
  • History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
  • 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 treatment with an anti-BCMA bispecific antibody.
  • Live attenuated vaccine within 4 weeks of the first dose
  • 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)

Additional Trial Information

Phase 2

Enrollment: 76 patients (estimated)

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