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 groupSponsors and collaborators
Source ClinicalTrials.gov