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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 147
- Locations
- 13
- Primary Endpoint
- Progression Free Survival
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Masitinib
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Intervention: Masitinib (Drug)
Masitinib
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Intervention: Bortezomib (Drug)
Masitinib
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Intervention: Dexamethasone (Drug)
Placebo
Placebo in combination with Bortezomib and Dexamethasone
Intervention: Placebo (Drug)
Placebo
Placebo in combination with Bortezomib and Dexamethasone
Intervention: Bortezomib (Drug)
Placebo
Placebo in combination with Bortezomib and Dexamethasone
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: Analysis to be conducted after a minimum of 201 events
Secondary Outcomes
- Overall Time to Progression(time from the date of randomization to the date of documented progression during the study)
- Overall Survival(Until death)