A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
C4 Therapeutics, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy 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…
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 CenterWest Hollywood, California
- START MidwestGrand Rapids, Michigan
- START San AntonioSan Antonio, Texas