RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Elranatamab
Specified dose on specified days
DRUG
Mezigdomide
Specified dose on specified days
DRUG
Dexamethasone
Specified dose on specified days
Locations (20)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Local Institution - 0026
Vancouver, British Columbia, Canada
Local Institution - 0027
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Local Institution - 0030
Suzhou, Jiangsu, China
Local Institution - 0031
Shanghai, Shanghai Municipality, China
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Evangelismos General Hospital of Athens
Athens, Attikí, Greece
Alexandra General Hospital of Athens
Athens, Attikí, Greece
St. Olavs Hospital
Trondheim, Sør-Trøndelag, Norway
Sykehusapoteket Ull
Oslo, Norway
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
University College London Hospital
London, England, United Kingdom