The purpose of the study is to compare the 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 have 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Masitinib 6 mg/kg/day
Matching placebo
Standard therapy (cycles of bortezomib)
Medical and Surgical Specialists
Galesburg, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Progression Free Survival
Time frame: Analysis to be conducted after a minimum of 201 events
Overall Time to Progression
Time frame: time from the date of randomization to the date of documented progression during the study
Overall Survival
Time frame: Until death
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Standard therapy (cycles of dexamethasone)
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Froedtert & Medical College of Wisconsin-CLCC
Milwaukee, Wisconsin, United States
CHU Estaing
Clermont-Ferrand, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
CH Le Mans
Le Mans, France
Hôpital Universitaire Dupuytren
Limoges, France
Hôpital Ambroise Paré
Marseille, France
...and 3 more locations