Cemsidomide plus dexamethasone for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open-label, single-arm, multicenter study where eligible participants receive oral cemsidomide combined with dexamethasone. The main goals are to measure antimyeloma activity (response rates) and to further characterize safety, tolerability, and the drug's pharmacokinetics and pharmacodynamics. Participants are adults with measurable relapsed or refractory multiple myeloma who have received multiple prior lines of therapy, including key drug classes. Investigators will track responses, adverse events, and laboratory markers over the treatment period to define the combination's activity and safety profile.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• Mayo Clinic - Arizona
  Phoenix, Arizona, United States Recruiting
• HonorHealth
  Scottsdale, Arizona, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• Berenson Cancer Center
  West Hollywood, California, United States Recruiting
• Mayo Clinic - Florida
  Jacksonville, Florida, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Binod Dhakal, M.D. — Medical College of Wisconsin
• Study coordinator: Study Medical Officer
• Email: clinicaltrials@c4therapeutics.com
• Phone: (617) 231-0700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.