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
A Phase 1b/2a, Multicenter, Open-label 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
3 other identifiers
interventional
62
8 countries
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Oct 2025
Shorter than P25 for phase_1 multiple-myeloma
22 active sites
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
May 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
October 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 3, 2027
February 2, 2026
January 1, 2026
1.6 years
May 16, 2025
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Number of participants with Adverse Events (AEs)
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
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
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
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
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)
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)
Secondary Outcomes (8)
International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)
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)
IMWG Uniform Response Criteria: 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 (At approximately 5 years)
IMWG Uniform Response Criteria: 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 (At approximately 5 years)
IMWG Uniform Response Criteria: 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 (At approximately 5 years)
IMWG Uniform Response Criteria: 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 (At approximately 5 years)
- +3 more secondary outcomes
Study Arms (2)
Phase 1
EXPERIMENTALPhase 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (22)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Local Institution - 0026
Vancouver, British Columbia, V5Z 4E6, Canada
Local Institution - 0027
Halifax, Nova Scotia, B3H 2Y9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0030
Suzhou, Jiangsu, 215006, China
Local Institution - 0031
Shanghai, Shanghai Municipality, 200434, China
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76, Greece
Alexandra General Hospital of Athens
Athens, Attikí, 115 28, Greece
St. Olavs Hospital
Trondheim, Sør-Trøndelag, 7030, Norway
Sykehusapoteket Ull
Oslo, 0450, Norway
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
University College London Hospital
London, England, W1T 7HA, United Kingdom
Royal Marsden Hospital (Sutton)
London, Sutton, SM2 5PT, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain the NCT# and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 16, 2025
First Posted
May 25, 2025
Study Start
October 7, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
June 3, 2027
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html