A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel
group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day to placebo in
the treatment of patients with relapsing multiple myeloma who received one previous therapy.
Patients will receive study treatment (masitinib/placebo) with the standard therapy
(bortezomib and dexamethazone).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival
Analysis to be conducted after a minimum of 201 events
No
Bertrand Arnulf, MD
Principal Investigator
Hôpital Saint-Louis, Paris - France
United States: Food and Drug Administration
AB06002
NCT01470131
May 2011
December 2014
Name | Location |
---|---|
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Medical and Surgical Specialists | Galesburg, Illinois 61401 |
Froedtert & Medical College of Wisconsin-CLCC | Milwaukee, Wisconsin 53226 |