Spots Global Cancer Trial Database for A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma

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Trial Identification

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

Official Title: 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

Study ID: NCT01470131

Conditions

Multiple Myeloma

Interventions

Study Description

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).