Conditions: Multiple Myeloma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.

Detailed description:

Arms:
arm 1: Severe Renal Impairment arm 2: End-stage renal disease arm 3: Normal renal function

Interventions: intervention 1: Lenalidomide intervention 2: Dexamethasone intervention 3: Dexamethasone intervention 4: Dexamethasone intervention 5: Elotuzumab (BMS-901608; HuLuc63)
Intervention descriptions: intervention 1: Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 2: Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 3: Tablets, Oral, 40 mg, weekly, on days 8, 15 \& 22 (cycle 1); days 8 \&22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 4: Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 5: Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Protocol document: