Conditions: Multiple Myeloma
Keywords: Onyx PR171 carfilzomib multiple myeloma relapsed refractory
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 312
Healthy volunteers: no

Brief summary:
To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma.

Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: carfilzomib intervention 2: carfilzomib
Intervention descriptions: intervention 1: Subjects will receive carfilzomib 20 mg/m2 as an intravenous bolus over 2 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. A maximum of 12 cycles will be administered. intervention 2: Subjects will receive carfilzomib intravenously over up to 10 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. In cycle 1, the dose is 20 mg/m2. If all doses are administered and well-tolerated over Cycle 1, beginning with Cycle 2 the dose will escalate to 27 mg/m2 cycle. A maximum of 12 cycles will be administered.

Protocol document: