A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma (FOCUS)
This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for subjects with multiple myeloma who have received all available approved treatment options and would otherwise be offered palliative care. These subjects must have received at least 3 prior treatments for their disease and be refractory to their most recent therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label, Phase 3 Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma|
- Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The primary objective of this study is to compare overall survival (OS) in patients with refractory multiple myeloma relapsed after at least 3 prior regimens who are randomized to receive either carfilzomib (Regimen C) or best supportive care (Regimen BSC).
- Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The secondary objectives of this study include investigating the effect of carfilzomib on other standard efficacy variables including PFS, overall response rate (ORR), disease control rate (DCR), and duration of response.
Additionally, this study will examine the safety profile of carfilzomib alone compared with best supportive care based on the incidence and severity of adverse events (AEs) and laboratory changes.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Best Supportive Care||
Drug: Best Supportive Care
Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid.
Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).
20mg/m2 IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m2 IV on Days 1,2,15, and 16.
Other Name: PR-171
Show 68 Study Locations
|Principal Investigator:||Roman Hajek, MD||University Hospital, Brno, Czech Republic|
|Principal Investigator:||Heinz Ludwig, MD||Center for Oncology and Haematology, Vienna, Austria|