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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle
Clearview Cancer Institute
Huntsville, Alabama, United States
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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