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

May 26, 2026 updated by: Celgene

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2
  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J E Child Comprehensive Cancer Centre
        • Contact:
          • Nizar Bahlis, Site 0032
          • Phone Number: 4032202801
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site
        • Contact:
          • Darrell White, Site 0027
          • Phone Number: 9024734642
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Guido Lancman, Site 0024
          • Phone Number: 4169462059
  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Not yet recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200434
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Contact:
          • Raphael Teipel, Site 0015
          • Phone Number: 493514582583
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Contact:
          • Katja Weisel, Site 0013
          • Phone Number: 4940741058787
      • Heidelberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg
        • Contact:
          • Marc-Steffen Raab, Site 0014
          • Phone Number: 496221565427
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens
        • Contact:
          • Sosana Delimpasi, Site 0011
          • Phone Number: 6944822722
      • Athens, Attikí, Greece, 115 28
        • Recruiting
        • Alexandra General Hospital of Athens
        • Contact:
          • MELETIOS DIMOPOULOS, Site 0012
          • Phone Number: +306932418798
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Sykehusapoteket Ull
        • Contact:
          • Fredrik Hellem Schjesvold, Site 0019
          • Phone Number: +4799697796
    • Sør-Trøndelag
      • Trondheim, Sør-Trøndelag, Norway, 7030
        • Recruiting
        • St. Olavs hospital
        • Contact:
          • Tobias Slordahl, Site 0017
          • Phone Number: 004791145009
  • Spain
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Maria Victoria Mateos Manteca, Site 0022
          • Phone Number: 34923291100
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Enrique Ocio, Site 0021
          • Phone Number: +34649391848
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Emma Searle, Site 0020
          • Phone Number: +447917554940
    • England
      • London, England, United Kingdom, W1T 7HA
        • Recruiting
        • University College London Hospital
        • Contact:
          • Selina Chavda, Site 0016
          • Phone Number: 02034472929
    • Sutton
      • London, Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton)
        • Contact:
          • Charlotte Pawlyn, Site 0018
          • Phone Number: 02087224000
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Luciano Costa, Site 0001
          • Phone Number: 205-934-9695
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital-Smilow Cancer Center
        • Contact:
          • Noffar Bar, Site 0029
          • Phone Number: 000-000-0000
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • David Siegel, Site 0028
          • Phone Number: 551-996-8704
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Jing Christine Ye, Site 0005
          • Phone Number: 734-232-0744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron®
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: Elranatamab
Specified dose on specified days
Other Names:
  • Elrexfio
  • PF-0686313
Experimental: Phase 2
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron®
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: Elranatamab
Specified dose on specified days
Other Names:
  • Elrexfio
  • PF-0686313

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with Serious AEs
Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs meeting protocol-defined DLT criteria
Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs leading to discontinuation
Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of deaths
Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Recommended Phase 2 Dose (RP2D)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Complete Response Rate (CRR)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Time to Response (TTR)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Duration of Response (DOR)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Progression-free Survival (PFS)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
IMWG Uniform Response Criteria: Overall Survival (OS)
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
Number of participants who achieve minimal residual disease (MRD) negativity
Time Frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
Defined as less than 1 in 10^5 nucleated cells in BMA for participants who achieve CR or better at any time after enrollment
From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 3, 2027

Study Registration Dates

First Submitted

May 16, 2025

First Submitted That Met QC Criteria

May 16, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA057-1040
  • 2025-522090-11 (Other Identifier: EU CTR)
  • U1111-1317-4901 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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