A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age
Description: 

A Phase III, multicenter, randomized, open-label study designed to evaluate the clinical benefit from the drug combination RVD without immediate high-dose therapy (HDT) folled by lenalidomide maintenance (Arm A) versus RVD plus HDT and PBSCT followed by lenalidomide maintenance (Arm B). To achieve the objectives of this study, data from this trial and a parallel trial in France will be combined together for analysis. To determine if, in the era of novel drugs, HDT is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival (by at least 9 months). Primary Objective: to compare progression-free survival (PFS) between the Arm A and Arm B. Secondary objectives:to compare the response rates (RR) between the two arms. To compare time to progression (TTP) between the two arms. To compare the overall survival (OS) between the two arms. To compare toxicity between the two arms. To define genetic prognostic groups evaluated by gene expression profiling (GEP). To examine the best treatment in each GEP-defined prognostic group. To compare quality of life (QOL) between the two arms. To collect medical resource utilization (MRU) information which may be used in economic evaluation models.

Study Number: 

I 210611

Phase: 
III
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT01208662

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