Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Arms (2)

1. type

   ACTIVE_COMPARATOR

   label

   Lenalidomide + Dexamethasone

   interventionNames

   1. Drug: Lenalidomide
   2. Drug: Dexamethasone

2. type

   EXPERIMENTAL

   label

   Lenalidomide + Dexamethasone + Elotuzumab

   interventionNames

   1. Drug: Lenalidomide
   2. Drug: Dexamethasone
   3. Biological: Elotuzumab (BMS-901608; HuLuc63)

Primary outcomes (1)

1. measure

   Progression-Free Survival (PFS)

   timeFrame

   From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

   description

   PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization