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

Amgen · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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multiple-myeloma
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
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