Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma
Study Details
The primary objectives of this study included the following:
Phase 1b:
• To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd)
• To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide
Phase 2:
• To estimate the antitumor activity of each combination regimen, as measured by overall response rate (ORR) and complete response rate (CRR)
• To evaluate the safety and tolerability of each combination regimens, as assessed by the type, incidence, severity and seriousness of adverse events, and abnormalities in selected laboratory analytes
Protocol Summary
Maximum Tolerated Dose (MTD)
Timeframe: 6 months
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 36 months
Overall Response Rate (ORR)
Timeframe: 14 months
Complete Response Rate (CRR)
Timeframe: 17 months
Population Pharmacokinetic (PK) Parameters - Apparent Clearance
Timeframe: 18 months
Population Pharmacokinetic (PK) Parameters - Volume of Distribution
Timeframe: 18 months
Duration of Response (DOR)
Timeframe: 42 months
Progression-Free Survival (PFS)
Timeframe: 42 months