Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma

Summary

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

Timeline

Start

2013-10-28

Primary completion

2019-09-23

Completion

2019-09-23

Drugs

Indications