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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorC4 Therapeutics, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Presence of myeloma in the central nervous system (CNS).

Systemic light chain amyloidosis

Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome

Myelodysplastic syndrome (MDS).

Trial design

Treatments tested in this trial

  • Cemsidomide
  • Dexamethasone

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

10
Arizona
HonorHealth85258, Scottsdale United States
California
Berenson Cancer Center90069, West Hollywood United States
Georgia
Winship Cancer Institute, Emory University30322, Atlanta United States
Indiana
Indiana University Health46202, Indianapolis United States

Sponsors and collaborators

C4 Therapeutics, Inc.

Lead sponsor