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Clinical Trials in the UK / NCT06988488
Recruiting Phase 1/2

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)

Elranatamab →Mezigdomide →Dexamethasone →

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
No
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)

FacilityCityRegionStatus
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

More Celgene trials in the UK

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma Active, not recruiting
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A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer Active, not recruiting
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve Active, not recruiting

Other trials for the same condition

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations Recruiting
A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma Recruiting
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma 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