RecruitingPhase 2NCT07284758

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


Sponsor

C4 Therapeutics, Inc.

Enrollment

100 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria11

  • 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.

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


Locations(3)

Berenson Cancer Center

West Hollywood, California, United States

START Midwest

Grand Rapids, Michigan, United States

START San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07284758


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