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NCT07280013PHASE1Recruiting

A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects

C4 Therapeutics, Inc.

Start Date

2/6/2026

Completion Date

6/1/2029

Summary

The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma. The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity. Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Diagnosis of multiple myeloma as defined by IMWG criteria * Measurable disease based on IMWG criteria * Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader) * ECOG performance status 0-2 Exclusion Criteria: * Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease * Participants with any active, uncontrolled bacterial, fungal, or viral infection * Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy * Administration with an investigational product within 30 days preceding the first dose of study intervention * Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function

Interventions

DRUG

Cemsidomide

BIOLOGICAL

Elranatamab

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Conditions

Multiple Myeloma (MM)

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

UC Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

UCLA Health, Jonsson Comprehensive Cancer Center

Santa Monica, California 90404

United States

University of Florida

Gainesville, Florida 32610

United States

University of Miami

Miami, Florida 33136

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

Indiana University

Indianapolis, Indiana 46202

United States

Norton Cancer Institute St. Matthews

Louisville, Kentucky 40207

United States

University of Maryland Greenbaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

START Midwest

Grand Rapids, Michigan 49546

United States

University of Nebraska

Omaha, Nebraska 68105

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Perlmutter Cancer Center at NYU Langone Hospital

Brooklyn, New York 11203

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah 84112

United States