Phase 2 Clinical Trial Studying the Effectiveness and Safety of Elranatamab by Itself in Participants with Relapsed/Refractory Multiple Myeloma

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Overview

The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

SparkCures ID 1125
Trial Phase Phase 2
Enrollment 180 Patients
Treatments
Tags
Trial Sponsors
  • Pfizer
NCT Identifier

NCT04649359

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:
      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
    • 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 Criteria:

    • Smoldering multiple myeloma
    • Active Plasma cell leukemia
    • Amyloidosis
    • 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)

US Trial Locations

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