A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

April 16, 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 Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Israel
      • Jerusalem, Israel, 9112001
        • Local Institution - 0020
    • Central District
      • Petah Tikva, Central District, Israel, 4910021
        • Local Institution - 0021
      • Ramat Gan, Central District, Israel, 5262100
        • Local Institution - 0030
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Local Institution - 0033
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Local Institution - 0035
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0018

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:

Participant has a history of RRMM, and must:

  • Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy.
  • Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy.

Exclusion Criteria:

• Must not have previously received alnuctamab or mezigdomide.

Note: 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: Part A
Drug: Dexamethasone
Specified dose on specified days
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
  • EM901
Experimental: Arm B1
Drug: Dexamethasone
Specified dose on specified days
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
  • EM901
Experimental: Arm B2
Drug: Dexamethasone
Specified dose on specified days
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
  • EM901
Experimental: Arm C1
Drug: Dexamethasone
Specified dose on specified days
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
  • EM901
Experimental: Arm C2
Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
  • EM901

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with serious AEs (SAEs)
Time Frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with AEs leading to discontinuation
Time Frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of deaths
Time Frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with Dose-limiting toxicities (DLTs)
Time Frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
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 (Up to approximately 5 years)
Phase 2 only
From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (Up to 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 (Up to approximately 5 years)
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 (Up to 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 (Up to approximately 5 years)
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 (Up to 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 (Up to approximately 5 years)
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 (Up to 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 (Up to approximately 5 years)
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 (Up to 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 (Up to approximately 5 years)
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 (Up to 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 (Up to approximately 5 years)
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 (Up to approximately 5 years)
Phase 1 only
From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to 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)

February 27, 2024

Primary Completion (Actual)

June 3, 2025

Study Completion (Actual)

June 3, 2025

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA058-002
  • 2023-504367-16-00 (Other Identifier: EU CTR)
  • U1111-1283-8970 (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/disclosure-commitment.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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