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

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma, Relapsed/Refractory Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT07284758

Run by

C4 Therapeutics, Inc.

People needed

100

Starts

2026-02-18

Expected to finish

2030-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be willing and able to provide signed informed consent for the study.
• Age ≥ 18 years at the time of signed consent.
• Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
• 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.
• Subjects need to have adequate organ function.
• Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.
• 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.
• 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.
• Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
• Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.

You may not qualify if…

• Presence of myeloma in the central nervous system (CNS).
• Subjects with any of the following:
• Systemic light chain amyloidosis
• Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
• Myelodysplastic syndrome (MDS).
• Previously treated with cemsidomide.
• Clinically significant impaired cardiac function or cardiac disease.
• Thromboembolic event within 3 months prior to enrollment.
• Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
• Uncontrolled active bacterial, fungal, or viral infection.
• Inability or difficulty swallowing tablets.
• NOTE: Other inclusion/exclusion criteria may apply, per protocol.

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
• Mayo Clinic - Arizona — Phoenix, Arizona, United States (enrolling)
• HonorHealth — Scottsdale, Arizona, United States (enrolling)
• Berenson Cancer Center — West Hollywood, California, United States (enrolling)
• Mayo Clinic - Florida — Jacksonville, Florida, United States (enrolling)
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
• Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Mayo Clinic - Minnesota — Rochester, Minnesota, United States (enrolling)
• Washington University/Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• The Tisch Cancer Institute/Mount Sinai — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• UNC Hospitals Adult Oncology Clinics — Chapel Hill, North Carolina, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• START San Antonio — San Antonio, Texas, United States (enrolling)
• University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
• MCW-Clinical Cancer Center at Froedtert Hospital Campus — Milwaukee, Wisconsin, United States (enrolling)
• Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital — London, United Kingdom, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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