Randomized Phase III Trial of Bortezomib LENalidomide and Dexamethasone (VRd) Versus Carfilzomib Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multip
Brief description of study
This two-stage randomized study is designed and powered to investigate both a maintenance and an induction question: (#1) following induction with a proteasome inhibitor–IMiD combination, whether indefinite versus limited lenalidomide maintenance therapy is superior; and (#2) whether CRd versus VRd induction treatment is superior. To implement these two comparisons, 756 patients are first randomized (R1) equally to either 12 cycles of VRd induction (Arm A) or 9 cycles of CRd induction (Arm B). Patients who have completed induction without experiencing disease progression or being withdrawn will be randomized again (R2) equally to 24 cycles of R maintenance and then observation (Arm C) or indefinite R maintenance until disease progression (Arm D). Patients will be stratified by intent to SCT at disease progression (R1) and by induction arm (R2).
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