Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

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

NCT ID: NCT07284758Sponsor: C4 Therapeutics, Inc.Last updated: 2026-03-12

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).

Arms & interventions

  • DrugCemsidomide

    dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle

  • DrugDexamethasone

    dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

Outcome measures

Primary

  • Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)

    Time frame: up to approximately 43 months

Secondary

  • Duration of response (DoR; IRC assessed)

    Time frame: up to approximately 43 months

  • Complete response (CR) rate (IRC assessed)

    Time frame: up to approximately 43 months

  • Time to response (IRC assessed)

    Time frame: up to approximately 43 months

  • Progression free survival (PFS; IRC assessed)

    Time frame: up to approximately 43 months

  • Overall survival (OS)

    Time frame: up to approximately 43 months

  • Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths

    Time frame: within 30 to 35 days of the last dose of study treatment

  • Plasma concentrations of cemsidomide

    Time frame: up to approximately 4 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (3)

Berenson Cancer Center

West Hollywood, California, 90069

Recruiting
James Berenson, MD · Contact

START Midwest

Grand Rapids, Michigan, 49546

Recruiting
Andrew Sochacki, MD · Contact

START San Antonio

San Antonio, Texas, 78229

Recruiting
Kyriakos Papadopoulos, MD · Contact
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma | Cancerify