AB06002 - Treatment for Relapsing Multiple Myeloma Study
Research type
Research Study
Full 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 dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy
IRAS ID
148839
Contact name
Charalampia KYRIAKOU
Contact email
Sponsor organisation
AB Science
Eudract number
2009-017930-35
Research summary
Multiple myeloma is a cancer of the bone marrow. It is characterised by bone destruction, kidney failure, an increased chance of catching infections, a decrease in red blood cells and an increase in calcium and a protein called M protein in the blood. The objective is to compare the efficacy and safety of masitinib 6 mg/kg/day to placebo in the treatment of patients with relapsing multiple myeloma who have received one previous therapy. The main purpose of the study is to look at Overall Progression Free Survival (PFS).
Patients will be randomised in 2 groups: 150 patients will receive masitinib at6 mg/kg/day in association with bortezomib and dexamethasone and remaining
150 patients will receive placebo in association with bortezomib and dexamethasone. The recruitment phase will take 18 months and patients will be treated until disease progression.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1037
Date of REC Opinion
22 Jul 2014
REC opinion
Further Information Favourable Opinion