Recruiting
Phase 1
Phase 2

Mezigdomide & Elranatamab

Sponsor:

Celgene

Code:

NCT06988488

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elranatamab

Mezigdomide

Dexamethasone

Study Details

Brief summary:

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).

Conditions

Multiple Myeloma

Study ID

NCT06988488

Start date

Oct 7, 2025

Status verified date

Sep, 2026

Completion date

Jun 3, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1

experimental: Phase 2

Interventions

Elranatamab

Specified dose on specified days

Mezigdomide

Specified dose on specified days

Dexamethasone

Specified dose on specified days

Primary outcome measure

  • Number of participants with Adverse Events (AEs) [ Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer ]
  • Number of participants with Serious AEs [ Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer ]
  • Number of participants with AEs meeting protocol-defined DLT criteria [ Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer ]
  • Number of deaths [ Time Frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer ]
  • Recommended Phase 2 Dose (RP2D) [ 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 (At approximately 5 years) ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Luciano Costa, Site 0001

205-934-9695

Yale New Haven Hospital-Smilow Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Noffar Bar, Site 0029

000-000-0000

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

David Siegel, Site 0028

551-996-8704

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jing Christine Ye, Site 0005

734-232-0744

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Nizar Bahlis, Site 0032

4032202801

QEII Health Sciences Centre - Victoria General Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Darrell White, Site 0027

9024734642

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Guido Lancman, Site 0024

4169462059

More Information

Sponsor

Celgene

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Celgene on 2026-09-02.