Conditions: Multiple Myeloma
Keywords: multiple myeloma relapsed multiple myeloma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 929
Healthy volunteers: no

Brief summary:
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

Detailed description:

Arms:
arm 1: Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle. arm 2: Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Interventions: intervention 1: Carfilzomib intervention 2: Bortezomib intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Carfilzomib is administered over 30 minutes as an infusion. intervention 2: Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval) intervention 3: Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.

Protocol document: