RecruitingPhase 1Phase 2NCT06988488

A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

Sponsor

Celgene

Enrollment

62 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — mezigdomide and elranatamab — in people with multiple myeloma (a blood cancer affecting plasma cells) that has returned or stopped responding to previous treatments. The goal is to find the safest and most effective dose and to evaluate whether the combination works. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory multiple myeloma - You have received 2–4 prior lines of anti-myeloma therapy (Phase 1) or 1–3 prior lines (Phase 2) - Your cancer is still measurable - Your ECOG performance score is 0 or 1 - You are using adequate contraception **You may NOT be eligible if...** - You have previously received mezigdomide - You have previously received a T-cell engaging therapy - You have had BCMA-targeted therapy (with some exceptions for CAR-T received more than 6 months ago) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElranatamab

Specified dose on specified days

DRUGMezigdomide

Specified dose on specified days

DRUGDexamethasone

Specified dose on specified days

Locations(22)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Local Institution - 0026

Vancouver, British Columbia, Canada

Local Institution - 0027

Halifax, Nova Scotia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Local Institution - 0030

Suzhou, Jiangsu, China

Local Institution - 0031

Shanghai, Shanghai Municipality, China

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Evangelismos General Hospital of Athens

Athens, Attikí, Greece

Alexandra General Hospital of Athens

Athens, Attikí, Greece

St. Olavs Hospital

Trondheim, Sør-Trøndelag, Norway

Sykehusapoteket Ull

Oslo, Norway

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

University College London Hospital

London, England, United Kingdom

Royal Marsden Hospital (Sutton)

London, Sutton, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06988488

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