NCT06163898

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
2 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

December 1, 2023

Last Update Submit

April 16, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

  • Number of participants with adverse events (AEs)

    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)

    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

    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

    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)

    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)

    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 Outcomes (7)

  • Complete Response Rate (CRR)

    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)

    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)

    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)

    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)

    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 more secondary outcomes

Study Arms (5)

Part A

EXPERIMENTAL
Drug: AlnuctamabDrug: MezigdomideDrug: Dexamethasone

Arm B1

EXPERIMENTAL
Drug: AlnuctamabDrug: MezigdomideDrug: Dexamethasone

Arm B2

EXPERIMENTAL
Drug: AlnuctamabDrug: MezigdomideDrug: Dexamethasone

Arm C1

EXPERIMENTAL
Drug: AlnuctamabDrug: MezigdomideDrug: Dexamethasone

Arm C2

EXPERIMENTAL
Drug: Alnuctamab

Interventions

AlnuctamabDRUG

Specified dose on specified days

Also known as: BMS-986349, CC-93269, EM901
Arm B1Arm B2Arm C1Arm C2Part A
MezigdomideDRUG

Specified dose on specified days

Also known as: BMS-986348, CC-92480
Arm B1Arm B2Arm C1Part A
DexamethasoneDRUG

Specified dose on specified days

Arm B1Arm B2Arm C1Part A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Must not have previously received alnuctamab or mezigdomide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution - 0033

Birmingham, Alabama, 35294, United States

Location

Local Institution - 0035

New Haven, Connecticut, 06511, United States

Location

Local Institution - 0018

New York, New York, 10065, United States

Location

Local Institution - 0021

Petah Tikva, Central District, 4910021, Israel

Location

Local Institution - 0030

Ramat Gan, Central District, 5262100, Israel

Location

Local Institution - 0020

Jerusalem, 9112001, Israel

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

February 27, 2024

Primary Completion

June 3, 2025

Study Completion

June 3, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See plan description
Access Criteria
See plan description
More information

Locations

US(3)IL(3)