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

Last updated: January 30, 2026
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Bone Neoplasm

Cancer/tumors

Treatment

Mezigdomide

Dexamethasone

Elranatamab

Clinical Study ID

NCT06988488
CA057-1040
2025-522090-11
U1111-1317-4901
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 ofanti-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

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 theexception of participants who have received autologous BCMA-targeted CART-celltherapy> 6 months from the start of study therapy

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 62
Treatment Group(s): 3
Primary Treatment: Mezigdomide
Phase: 1/2
Study Start date:
October 07, 2025
Estimated Completion Date:
June 03, 2027

Connect with a study center

  • Local Institution - 0032

    Calgary, Alberta T2N 5G2
    Canada

    Site Not Available

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary 5913490, Alberta 5883102 T2N 5G2
    Canada

    Active - Recruiting

  • Local Institution - 0032

    Calgary 5913490, Alberta 5883102 T2N 5G2
    Canada

    Site Not Available

  • Local Institution - 0026

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Local Institution - 0026

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • Local Institution - 0027

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Local Institution - 0027

    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
    Canada

    Site Not Available

  • Local Institution - 0024

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Active - Recruiting

  • Local Institution - 0030

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Local Institution - 0030

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • Local Institution - 0031

    Shanghai, Shanghai 200434
    China

    Site Not Available

  • Local Institution - 0031

    Shanghai 1796236, Shanghai Municipality 1796231 200434
    China

    Site Not Available

  • Local Institution - 0015

    Dresden, 01307
    Germany

    Site Not Available

  • Local Institution - 0015

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden 2935022, 01307
    Germany

    Active - Recruiting

  • Local Institution - 0013

    Hamburg, 20246
    Germany

    Site Not Available

  • Local Institution - 0013

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg 2911298, 20246
    Germany

    Active - Recruiting

  • Local Institution - 0014

    Heidelberg, D-69120
    Germany

    Site Not Available

  • Local Institution - 0014

    Heidelberg 2907911, D-69120
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg 2907911, 69120
    Germany

    Active - Recruiting

  • Local Institution - 0011

    Athens, Attikí 106 76
    Greece

    Site Not Available

  • Local Institution - 0012

    Athens, Attikí 115 28
    Greece

    Site Not Available

  • Alexandra General Hospital of Athens

    Athens 264371, Attikí 115 28
    Greece

    Active - Recruiting

  • Evangelismos General Hospital of Athens

    Athens 264371, Attikí 106 76
    Greece

    Active - Recruiting

  • Local Institution - 0011

    Athens 264371, Attikí 106 76
    Greece

    Site Not Available

  • Local Institution - 0012

    Athens 264371, Attikí 115 28
    Greece

    Site Not Available

  • Local Institution - 0017

    Trondheim, Sør-Trøndelag 7030
    Norway

    Site Not Available

  • Local Institution - 0017

    Trondheim 3133880, Sør-Trøndelag 7030
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim 3133880, Sør-Trøndelag 7030
    Norway

    Active - Recruiting

  • Local Institution - 0019

    Oslo, 0450
    Norway

    Site Not Available

  • Local Institution - 0019

    Oslo 3143244, 0450
    Norway

    Site Not Available

  • Sykehusapoteket Ull

    Oslo 3143244, 0450
    Norway

    Active - Recruiting

  • Local Institution - 0021

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Active - Recruiting

  • Local Institution - 0021

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Local Institution - 0022

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca 3111108, 37007
    Spain

    Active - Recruiting

  • Local Institution - 0022

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • Local Institution - 0016

    London, England W1T 7HA
    United Kingdom

    Site Not Available

  • Local Institution - 0016

    London 2643743, England 6269131 W1T 7HA
    United Kingdom

    Site Not Available

  • University College London Hospital

    London 2643743, England 6269131 W1T 7HA
    United Kingdom

    Active - Recruiting

  • Local Institution - 0018

    London, Sutton SM2 5PT
    United Kingdom

    Site Not Available

  • Local Institution - 0018

    London 2643743, Sutton SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital (Sutton)

    London 2643743, Sutton SM2 5PT
    United Kingdom

    Active - Recruiting

  • Local Institution - 0020

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Local Institution - 0020

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester 2643123, M20 4BX
    United Kingdom

    Active - Recruiting

  • Local Institution - 0001

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • Local Institution - 0001

    Birmingham 4049979, Alabama 4829764 35294-3300
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35294-3300
    United States

    Active - Recruiting

  • Local Institution - 0029

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Local Institution - 0029

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Yale New Haven Hospital-Smilow Cancer Center

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Local Institution - 0028

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Local Institution - 0028

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Local Institution - 0005

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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