Conditions: Relapsed Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 84
Healthy volunteers: no

Brief summary:
To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma

Detailed description:

Arms:
arm 1: Treatment during Cycles 1 through 12 consisted of carfilzomib (15, 20, or 20/27 mg/m²) on Days 1, 2, 8, 9, 15, and 16; lenalidomide (10, 15, 20, or 25 mg) on Days 1 to 21; and low-dose dexamethasone (40 mg) given 30 minutes to 4 hours before the carfilzomib dose on Days 1, 8, and 15, as well as on Day 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.

Interventions: intervention 1: Carfilzomib intervention 2: Lenalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Carfilzomib for Injection was administered intravenously over 10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for the first 12 cycles. Each dose of Carfilzomib for Injection was normalized to body surface area. intervention 2: Lenalidomide was administered orally on Days 1 to 21 of each 28-day cycle. intervention 3: Dexamethasone 40 mg orally or intravenous equivalent was administered 30 minutes to 4 hours before carfilzomib on Days 1, 8, and 15, as well as on Day 22 of each 28-day cycle.

Protocol document: