Objectives and Endpoints
Toxicities, death, diarrhea, toxicities, cytopenias, vomiting, rash, nausea,
PERIPHERAL NEUROPATHY, CYTOPENIAS, MYELOMA, ENCEPHALOPATHY
The primary end point of this study was to evaluate the overall response rate to induction therapy (ORR). Response rates were evaluated using the International Myeloma Working Group Response Criteria. Secondary objectives included evaluation of toxicities, PFS, and overall survival (OS). Toxicities of interest included cytopenias, nausea, vomiting and diarrhea, rash, peripheral neuropathy, and posterior reversible encephalopathy. PFS was defined as the time from registration to the date of first documented progression or death. OS was defined as the time from registration to the date of death.An ORR of ≥80% was judged as promising for further evaluation. Further evaluation would not be warranted if the ORR was <50%. Simon’s 2 stage (MiniMax) design was used. In the first stage, 5 or more responses in 7 enrolled patients were required to proceed. In the second stage, an additional 13 patients were to be enrolled for a total sample size of 