Conditions: Multiple Myeloma Renal Insufficiency
Keywords: Myeloma Renal Insufficiency Proteasome Hematological carfilzomib PR-171
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).

Detailed description:

Arms:
arm 1: Carfilzomib, 15 mg/m², was administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.

If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.

Interventions: intervention 1: Carfilzomib
Intervention descriptions: intervention 1: Carfilzomib was administered intravenously (IV) at a rate of approximately 10 mL/minute.

Protocol document: