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NCT06988488PHASE1, PHASE2Recruiting

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

Celgene

Start Date

10/7/2025

Completion Date

6/3/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2). * Measurable MM by local laboratory. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. * Adherence to contraception requirements. Exclusion Criteria: * Prior treatment with mezigdomide. * Prior treatment with T cell engaging or T cell engager (TCE). * Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy\> 6 months from the start of study therapy * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Elranatamab

DRUG

Mezigdomide

DRUG

Dexamethasone

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Conditions

Multiple Myeloma

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut 06510

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Local Institution - 0026

Vancouver, British Columbia V5Z 4E6

Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia B3H 2Y9

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Local Institution - 0030

Suzhou, Jiangsu 215006

China

Local Institution - 0031

Shanghai, Shanghai Municipality 200434

China

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Evangelismos General Hospital of Athens

Athens, Attikí 106 76

Greece

Alexandra General Hospital of Athens

Athens, Attikí 115 28

Greece

St. Olavs Hospital

Trondheim, Sør-Trøndelag 7030

Norway

Sykehusapoteket Ull

Oslo, 0450

Norway

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007

Spain

University College London Hospital

London, England W1T 7HA

United Kingdom

Royal Marsden Hospital (Sutton)

London, Sutton SM2 5PT

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom