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

NCT06988488 · tracked via the Priya Life Science UK tracker

Sponsor

Celgene

Phase

Phase 1/2

Started

2025-10-07

Last updated

2026-09-02

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

ElranatamabMezigdomideDexamethasone

Elranatamab: Specified dose on specified days

Mezigdomide: Specified dose on specified days

Dexamethasone: Specified dose on specified days

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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)

Trial sites (22)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
Yale New Haven Hospital-Smilow Cancer Center	New Haven	Connecticut	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	Recruiting
Arthur J E Child Comprehensive Cancer Centre	Calgary	Alberta	Recruiting
Local Institution - 0026	Vancouver	British Columbia	Not Yet Recruiting
QEII Health Sciences Centre - Victoria General Site	Halifax	Nova Scotia	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
Local Institution - 0030	Suzhou	Jiangsu	Not Yet Recruiting
Tongji University - Shanghai Fourth People's Hospital	Shanghai	Shanghai Municipality	Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden	Dresden	Germany	Recruiting
Universitaetsklinikum Hamburg-Eppendorf	Hamburg	Germany	Recruiting
Universitaetsklinikum Heidelberg	Heidelberg	Germany	Recruiting
Evangelismos General Hospital of Athens	Athens	Attikí	Recruiting
Alexandra General Hospital of Athens	Athens	Attikí	Recruiting
St. Olavs Hospital	Trondheim	Sør-Trøndelag	Recruiting
Sykehusapoteket Ull	Oslo	Norway	Recruiting
Hospital Universitario Marqués de Valdecilla	Santander	Cantabria	Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca	Spain	Recruiting
University College London Hospital	London	England	Recruiting
Royal Marsden Hospital (Sutton)	London	Sutton	Recruiting
The Christie NHS Foundation Trust	Manchester	United Kingdom	Recruiting

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A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06988488 on ClinicalTrials.gov ↗ ← All trials in the UK