Conditions: Lymphoma Multiple Myeloma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 646
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Lenalidomide intervention 2: Dexamethasone intervention 3: Dexamethasone (Oral) intervention 4: Dexamethasone (IV) intervention 5: Elotuzumab (BMS-901608; HuLuc63)
Intervention descriptions: intervention 1: Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 2: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 3: On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.

On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 4: On weeks without Elotuzumab dosing: Not Applicable (N/A)

On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 5: Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Protocol document: