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NCT07284758PHASE2Recruiting

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

C4 Therapeutics, Inc.

Start Date

2/18/2026

Completion Date

3/1/2030

Summary

This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Be willing and able to provide signed informed consent for the study. 2. Age ≥ 18 years at the time of signed consent. 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. 4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care. 5. Subjects need to have adequate organ function. 6. Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1. 7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment. 8. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment. 9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation. 10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation. Exclusion Criteria: 1. Presence of myeloma in the central nervous system (CNS). 2. Subjects with any of the following: * Systemic light chain amyloidosis * Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome * Myelodysplastic syndrome (MDS). 3. Previously treated with cemsidomide. 4. Clinically significant impaired cardiac function or cardiac disease. 5. Thromboembolic event within 3 months prior to enrollment. 6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years. 7. Uncontrolled active bacterial, fungal, or viral infection. 8. Inability or difficulty swallowing tablets. NOTE: Other inclusion/exclusion criteria may apply, per protocol.

Interventions

DRUG

Cemsidomide

DRUG

Dexamethasone

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Conditions

Multiple MyelomaRelapsed/Refractory Multiple Myeloma

Locations

HonorHealth

Scottsdale, Arizona 85258

United States

Berenson Cancer Center

West Hollywood, California 90069

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Indiana University Health

Indianapolis, Indiana 46202

United States

START Midwest

Grand Rapids, Michigan 49546

United States

Washington University/Siteman Cancer Center

St Louis, Missouri 63108

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

START San Antonio

San Antonio, Texas 78229

United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin 53792

United States