NCT01470131

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Masitinib	Masitinib 6 mg/kg/day
DRUG	Placebo	Matching placebo
DRUG	Bortezomib	Standard therapy (cycles of bortezomib)
DRUG	Dexamethasone	Standard therapy (cycles of dexamethasone)

Timeline

• Start date: 2011-05-01
• Primary completion: 2017-01-04
• Completion: 2017-02-01
• First posted: 2011-11-11
• Last updated: 2018-12-19

Locations

13 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study