Cemsidomide plus dexamethasone for relapsed or refractory multiple myeloma

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

This will try cemsidomide with dexamethasone to see if it works and is safe for adults with relapsed or refractory multiple myeloma who have had several prior treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: C4 Therapeutics, Inc. (industry)
• Drugs / interventions: CAR-T, chimeric antigen receptor
• Locations: 3 sites (West Hollywood, California and 2 other locations)
• Trial ID: NCT07284758 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with documented, measurable relapsed or refractory multiple myeloma who have received at least three prior anti-myeloma regimens including an immunomodulatory drug, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy (unless not available locally) are the intended participants.

Not a fit: Patients who are newly diagnosed, who have not received the required prior therapies, who have inadequate organ function, unresolved severe toxicities from prior treatments, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this combination could offer an additional effective treatment option for patients with heavily pretreated relapsed or refractory multiple myeloma.

How similar studies have performed: Other early-phase programs of next-generation cereblon modulators combined with dexamethasone have shown promising activity in relapsed multiple myeloma, but the benefit of cemsidomide in this heavily pretreated setting is still being defined.

Eligibility criteria

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 this trial is running

West Hollywood, California and 2 other locations

• Berenson Cancer Center — West Hollywood, California, United States (RECRUITING)
• START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
• START San Antonio — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Binod Dhakal, M.D. — Medical College of Wisconsin
• Study coordinator: Study Medical Officer

Conditions: Multiple Myeloma, Relapsed/Refractory Multiple Myeloma, cemsidomide, dexamethasone