Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

NCT ID: NCT05020236Sponsor: PfizerLast updated: 2026-05-05

Summary

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide 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 evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in 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.

Arms & interventions

  • DrugElranatamab

    subcutaneous

  • DrugDaratumumab

    Daratumumab / hyaluronidase, subcutaneous

  • DrugPomalidomide

    oral

  • DrugDexamethasone

    oral

Outcome measures

Primary

  • Part 1 Safety Lead-In: Incidence of dose limiting toxicities

    Time frame: First 42 days after first elranatamab dose

  • Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months

  • Part 3: Frequency of treatment-emergent adverse events

    Time frame: First 84 days after first elranatamab dose

Secondary

  • Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  • Overall survival

    Time frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  • Objective response rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  • Duration of response per International Myeloma Working Group criteria

    Time frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  • Time to response per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of confirmed objective response, assessed up to 51 months

  • Complete response rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  • Duration of complete response per International Myeloma Working Group criteria

    Time frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  • Minimal residual disease negativity rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  • Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  • Progression free survival on next-line treatment per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months

  • Frequency of treatment-emergent adverse events

    Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.

  • Frequency of abnormal laboratory results

    Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.

  • Rate of Grade ≥2 cytokine release syndrome

    Time frame: First 28 days after first elranatamab dose

  • Elranatamab pharmacokinetics by pre- and post-dose concentrations

    Time frame: From date of first dose through up to 14 days after date of last dose of elranatamab

  • Elranatamab immunogenicity by anti-drug antibodies against elranatamab

    Time frame: From date of first dose through up to 14 days after date of last dose of elranatamab

  • Daratumumab pharmacokinetics by pre-dose concentrations

    Time frame: From date of first dose through up to 14 days after date of last dose of daratumumab

  • Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30

    Time frame: From date of informed consent through up to 35 days after date of last dose of study intervention

  • Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

    Time frame: From date of informed consent through up to 35 days after date of last dose of study intervention

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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. * 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. * Plasma cell leukemia. * Amyloidosis. * POEMS Syndrome. * 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. * 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.

Study locations (11)

Clovis Community Medical Center

Clovis, California, 93611

Active Not Recruiting

Community Regional Medical Center

Fresno, California, 93721

Active Not Recruiting

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, 80524

Active Not Recruiting

UCHealth Greeley Hospital

Greeley, Colorado, 80634

Active Not Recruiting

Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, 33180

Recruiting

Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida, 33065

Recruiting

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, 33442

Recruiting

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, 33021

Recruiting

University of Miami Hospital and Clinics

Miami, Florida, 33136

Recruiting

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, 10021

Recruiting

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065

Recruiting