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

NCT ID: NCT06988488

Last Updated: 2026-02-02

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

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-07

Study Completion Date

2027-06-03

Brief Summary

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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).

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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Phase 1

Group Type EXPERIMENTAL

Elranatamab

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

Phase 2

Group Type EXPERIMENTAL

Elranatamab

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

Interventions

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Elranatamab

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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Elrexfio PF-0686313 BMS-986348 CC-92480 Decadron®

Eligibility Criteria

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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
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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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Local Institution - 0026

Vancouver, British Columbia, Canada

Site Status NOT_YET_RECRUITING

Local Institution - 0027

Halifax, Nova Scotia, Canada

Site Status NOT_YET_RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Local Institution - 0030

Suzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

Local Institution - 0031

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Site Status RECRUITING

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Evangelismos General Hospital of Athens

Athens, Attikí, Greece

Site Status RECRUITING

Alexandra General Hospital of Athens

Athens, Attikí, Greece

Site Status RECRUITING

St. Olavs Hospital

Trondheim, Sør-Trøndelag, Norway

Site Status RECRUITING

Sykehusapoteket Ull

Oslo, , Norway

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status RECRUITING

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

University College London Hospital

London, England, United Kingdom

Site Status RECRUITING

Royal Marsden Hospital (Sutton)

London, Sutton, United Kingdom

Site Status RECRUITING

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United States Canada China Germany Greece Norway Spain United Kingdom

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Luciano Costa, Site 0001

Role: primary

205-934-9695

Noffar Bar, Site 0029

Role: primary

000-000-0000

David Siegel, Site 0028

Role: primary

551-996-8704

Jing Christine Ye, Site 0005

Role: primary

734-232-0744

Nizar Bahlis, Site 0032

Role: primary

4032202801

Site 0026

Role: primary

Site 0027

Role: primary

Guido Lancman, Site 0024

Role: primary

4169462059

Site 0030

Role: primary

Site 0031

Role: primary

Raphael Teipel, Site 0015

Role: primary

493514582583

Katja Weisel, Site 0013

Role: primary

4940741058787

Marc-Steffen Raab, Site 0014

Role: primary

496221565427

Sosana Delimpasi, Site 0011

Role: primary

6944822722

MELETIOS DIMOPOULOS, Site 0012

Role: primary

+306932418798

Tobias Slordahl, Site 0017

Role: primary

004791145009

Fredrik Hellem Schjesvold, Site 0019

Role: primary

+4799697796

Enrique Ocio, Site 0021

Role: primary

+34649391848

Maria Victoria Mateos Manteca, Site 0022

Role: primary

34923291100

Selina Chavda, Site 0016

Role: primary

02034472929

Charlotte Pawlyn, Site 0018

Role: primary

02087224000

Emma Searle, Site 0020

Role: primary

+447917554940

Related Links

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Other Identifiers

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2025-522090-11

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1317-4901

Identifier Type: OTHER

Identifier Source: secondary_id

CA057-1040

Identifier Type: -

Identifier Source: org_study_id

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