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RecruitingInterventionalPhase 1

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

NCT ID: NCT06215118Sponsor: PfizerLast updated: 2026-06-10

Summary

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Arms & interventions

  • DrugElranatamab

    BCMA-CD3 bispecific antibody

  • DrugIberdomide

    cereblon-modulating agent

Outcome measures

Primary

  • Part 1: Number of participants with dose limiting toxicity (DLT)

    Dose limiting toxicity rate based on dose limiting toxicity evaluable participants

    Time frame: Cycle 1, about 28 days

  • Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment

    Number of participants with AE among participants who take at least 1 dose of study intervention. AEs are categorized by seriousness and relationship to treatment. Relatedness to study drug is assessed by investigator.

    Time frame: Assessed from baseline up to 90 days after last dose of study treatment

Secondary

  • Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment

    Time frame: Assessed from baseline up to 90 days after last dose of study treatment

  • Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity

    Time frame: Assessed from baseline up to 90 days after last dose of study treatment

  • Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities

    Time frame: Assessed from baseline up to 90 days after last dose of study treatment

  • Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Time to Response (TTR)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Duration of Response (DOR)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Duration of Complete Response (DOCR)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Time of Progression Free Survival (PFS)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Time of Overall Survival (OS)

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Concentrations of elranatamab

    Time frame: Assessed for approximately 2 years

  • Part 1 and Part 2: Concentrations of iberdomide

    Time frame: Assessed for approximately 4 months

  • Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab

    Time frame: Assessed for approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Prior diagnosis of multiple myeloma as defined by IMWG criteria * Measurable disease based on IMWG criteria 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 hour by UPEP * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65) * Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor. * Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor. * ECOG performance status 0-1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 Exclusion Criteria: * Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome * Impaired cardiovascular function or clinically significant cardiovascular diseases * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease * Participants with 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: * BCMA-directed or CD3 redirecting therapy * Iberdomide (CC-220) or Mezigdomide * Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study * Administration with an investigational product within 30 days preceding the first dose of study intervention * Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Study locations (34)

Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

Coral Gables, Florida, 33146

Recruiting

University of Miami Hospital and Clinics Deerfield Beach

Deerfield Beach, Florida, 33442

Recruiting

Sylvester Comprehensive Cancer Center- Doral

Doral, Florida, 33166

Recruiting

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting

University of Miami Hospital and Clinics

Miami, Florida, 33136

Recruiting

Sylvester Comprehensive Cancer Center Kendall

Miami, Florida, 33176

Recruiting

Sylvester Comprehensive Cancer Center Plantation

Plantation, Florida, 33324

Recruiting

Emory University Hospital Midtown

Atlanta, Georgia, 30308

Recruiting

Emory University Hospital

Atlanta, Georgia, 30322

Recruiting

Winship Cancer Institute

Atlanta, Georgia, 30322

Recruiting

Indiana CTSI Clinical Research Center (ICRC)

Indianapolis, Indiana, 46202

Recruiting

Indiana University Health University Hospital

Indianapolis, Indiana, 46202

Recruiting

Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC)

Indianapolis, Indiana, 46202

Recruiting

University of Maryland

Baltimore, Maryland, 21201

Recruiting

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, 02459

Recruiting

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655

Recruiting

Methodist Hospital

Omaha, Nebraska, 68114

Recruiting

Oncology Hematology West P.C. dba Nebraska Cancer - Methodist

Omaha, Nebraska, 68114

Recruiting

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Recruiting

MSK Basking Ridge

Basking Ridge, New Jersey, 07920

Recruiting

MSK Monmouth

Middletown, New Jersey, 07748

Recruiting

MSK Bergen

Montvale, New Jersey, 07645

Recruiting

MSK Commack

Commack, New York, 11725

Recruiting

MSK Westchester

Harrison, New York, 10604

Recruiting

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101

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

MSK Nassau

Uniondale, New York, 11553

Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting

University of Washington

Seattle, Washington, 98195

Recruiting

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting