Conditions: Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of increasing doses of carfilzomib in combination with dexamethasone

Detailed description:

Arms:
arm 1: Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.

Interventions: intervention 1: Carfilzomib intervention 2: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: