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

NCT ID: NCT06163898

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

Group Type EXPERIMENTAL

Alnuctamab

Intervention Type DRUG

Specified dose on specified days

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Arm B1

Group Type EXPERIMENTAL

Alnuctamab

Intervention Type DRUG

Specified dose on specified days

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Arm B2

Group Type EXPERIMENTAL

Alnuctamab

Intervention Type DRUG

Specified dose on specified days

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Arm C1

Group Type EXPERIMENTAL

Alnuctamab

Intervention Type DRUG

Specified dose on specified days

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Arm C2

Group Type EXPERIMENTAL

Alnuctamab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Alnuctamab

Specified dose on specified days

Intervention Type DRUG

Mezigdomide

Specified dose on specified days

Intervention Type DRUG

Dexamethasone

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986349 CC-93269 EM901 BMS-986348 CC-92480

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0033

Birmingham, Alabama, United States

Site Status

Local Institution - 0035

New Haven, Connecticut, United States

Site Status

Local Institution - 0018

New York, New York, United States

Site Status

Local Institution - 0021

Petah Tikva, Central District, Israel

Site Status

Local Institution - 0030

Ramat Gan, Central District, Israel

Site Status

Local Institution - 0020

Jerusalem, , Israel

Site Status

Countries

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United States Israel

Related Links

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Other Identifiers

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2023-504367-16-00

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1283-8970

Identifier Type: OTHER

Identifier Source: secondary_id

CA058-002

Identifier Type: -

Identifier Source: org_study_id

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