Phase 1 / 2 Study of Elranatamab in People with Relapsed/Refractory Multiple Myeloma



The goal of this clinical trial is to evaluate the safety and effectiveness of different doses and dose intervals of Elranatamab in people with relapsed/refractory multiple myeloma.

SparkCures ID 1211
Trial Phase Phase 2
Enrollment 76 Patients
Trial Sponsors
  • Pfizer
NCT Identifier


Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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
  • 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)

US Trial Locations

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