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
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