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TerminatedNCT06163898Updated Apr 21, 2026

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

A Phase 1 interventional study of Alnuctamab and Mezigdomide in Multiple Myeloma, sponsored by Celgene. Terminated at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Celgene · Phase 1, Interventional, and Treatment

Why this study was terminated
Business objectives have changed

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 4 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Must not have previously received alnuctamab or mezigdomide.

Note: Other protocol-defined inclusion/exclusion criteria apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Part A

    Drug: Alnuctamab · Drug: Mezigdomide · Drug: Dexamethasone

  • Experimental
    Arm B1

    Drug: Alnuctamab · Drug: Mezigdomide · Drug: Dexamethasone

  • Experimental
    Arm B2

    Drug: Alnuctamab · Drug: Mezigdomide · Drug: Dexamethasone

  • Experimental
    Arm C1

    Drug: Alnuctamab · Drug: Mezigdomide · Drug: Dexamethasone

  • Experimental
    Arm C2

    Drug: Alnuctamab

Interventions

  • DrugAlnuctamab

    Specified dose on specified days

    Also known as: BMS-986349, CC-93269, EM901

  • DrugMezigdomide

    Specified dose on specified days

    Also known as: BMS-986348, CC-92480

  • DrugDexamethasone

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Overall Response Rate (ORR)

    Phase 2 only

    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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. ORR

    Phase 1 only

    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)

07

Study locations

6 sites
  • Local Institution - 0033
    Birmingham, Alabama 35294, United States
  • Local Institution - 0035
    New Haven, Connecticut 06511, United States
  • Local Institution - 0018
    New York, New York 10065, United States
  • Local Institution - 0021
    Petah Tikva, Central District 4910021, Israel
  • Local Institution - 0030
    Ramat Gan, Central District 5262100, Israel
  • Local Institution - 0020
    Jerusalem, 9112001, Israel
08

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06163898
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Dec 11, 2023
Start date
Feb 27, 2024
Primary completion
Jun 3, 2025
Completion
Jun 3, 2025
Last update
Apr 21, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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