A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Masitinib
* Drug: Placebo
* Drug: Bortezomib
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masitinib<br>Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone | Drug: Masitinib<br>* Masitinib 6 mg/kg/day<br>* Other names: AB1010;Drug: Bortezomib<br>* Standard therapy (cycles of bortezomib)<br>* Other names: Velcade;Drug: Dexamethasone<br>* Standard therapy (cycles of dexamethasone)<br>* Other names: Dexasone;|
| Placebo Comparator: Placebo<br>Placebo in combination with Bortezomib and Dexamethasone | Drug: Placebo<br>* Matching placebo<br>Drug: Bortezomib<br>* Standard therapy (cycles of bortezomib)<br>* Other names: Velcade;Drug: Dexamethasone<br>* Standard therapy (cycles of dexamethasone)<br>* Other names: Dexasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Analysis to be conducted after a minimum of 201 events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Time to Progression |  | time from the date of randomization to the date of documented progression during the study | 
| Overall Survival |  | Until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone