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

AB Science

Status and phase: Terminated; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Placebo; Drug: Dexamethasone; Drug: Bortezomib; Drug: Masitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470131

AB06002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with confirmed multiple myeloma requiring systemic therapy. A
2. 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
3. Patient with measurable progressive disease

Exclusion criteria

1. Patient with peripheral neuropathy Grade >2
2. Patient with hypersensitivity to bortezomib, boron or dexamethasone
3. Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
4. Patient who received bortezomib within 6 months of randomization to this study
5. Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
6. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 2 patient groups, including a placebo group

Masitinib

Experimental group

Description:

Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone

Treatment:

Drug: Masitinib

Drug: Bortezomib

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

Placebo in combination with Bortezomib and Dexamethasone

Treatment:

Drug: Bortezomib

Drug: Placebo

Drug: Dexamethasone