A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
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
Study locations (3)
Berenson Cancer Center
West Hollywood, California, 90069
START Midwest
Grand Rapids, Michigan, 49546
START San Antonio
San Antonio, Texas, 78229