A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT01470131
- Lead Sponsor
- AB Science
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 147
- Patient with confirmed multiple myeloma requiring systemic therapy. A
- Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) to one previous line of treatment
- Patient with measurable progressive disease
- Patient with peripheral neuropathy Grade >2
- Patient with hypersensitivity to bortezomib, boron or dexamethasone
- Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
- Patient who received bortezomib within 6 months of randomization to this study
- Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
- Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo in combination with Bortezomib and Dexamethasone Placebo Bortezomib Placebo in combination with Bortezomib and Dexamethasone Masitinib Dexamethasone Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone Masitinib Masitinib Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone Masitinib Bortezomib Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone Placebo Dexamethasone Placebo in combination with Bortezomib and Dexamethasone
- Primary Outcome Measures
Name Time Method Progression Free Survival Analysis to be conducted after a minimum of 201 events
- Secondary Outcome Measures
Name Time Method Overall Time to Progression time from the date of randomization to the date of documented progression during the study Overall Survival Until death
Trial Locations
- Locations (13)
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
CHU Estaing
🇫🇷Clermont Ferrand, France
CH Le Mans
🇫🇷Le Mans, France
Medical and Surgical Specialists
🇺🇸Galesburg, Illinois, United States
Hôpital de l'Hôtel Dieu
🇫🇷Nantes, France
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Hôpital Ambroise Paré
🇫🇷Marseille, France
Centre Hospitalier Saint Jean
🇫🇷Perpignan, France
Hôpital Universitaire Dupuytren
🇫🇷Limoges, France
Froedtert & Medical College of Wisconsin-CLCC
🇺🇸Milwaukee, Wisconsin, United States
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
Hôpital Saint Louis
🇫🇷Paris, France
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States