A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: masitinib 6 mg/kg/day Type: Drug
Name: placebo Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Patient with confirmed multiple myeloma requiring systemic therapy. All three criteria must be met:

- Clonal bone marrow plasma cells > 10%

- Presence of serum and/or urinary monoclonal protein

- Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:

- Hypercalcemia: serum calcium > 11.5 mg/100 ml or

- Renal insufficiency: serum creatinine > 173 µmol/l

- Anemia: normochromic, normocytic with a hemoglobin value of > 2g/100 ml below the lower limit of normal or a hemoglobin value < 10g/100 ml

- Bone lesions: lytic lesions, severe osteopenia or pathologic fractures

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 defined by at least one of the following two measurements:

- Serum M-protein ≥ 1 g/dL

- Urine M-protein ≥ 200 mg/24h

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)
Locations
Medical and Surgical Specialists
Galesburg, Illinois, United States
Status: Recruiting
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Status: Recruiting
Carolinas Medical Center
Charlotte, North Carolina, United States
Status: Recruiting
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Status: Recruiting
Froedtert & Medical College of Wisconsin-CLCC
Milwaukee, Wisconsin, United States
Status: Recruiting
CHU Estaing
Clermont Ferrand, France
Status: Recruiting
Centre Hospitalier Sud Francilien
Corbeil Essonne, France
Status: Recruiting
CH Le Mans
Le Mans, France
Status: Recruiting
Hôpital Universitaire Dupuytren
Limoges, France
Status: Recruiting
Hôpital Ambroise Paré
Marseille, France
Status: Recruiting
Hôpital de l'Hôtel Dieu
Nantes, France
Status: Recruiting
Hôpital Saint Louis
Paris, France
Status: Recruiting
Centre Hospitalier Saint Jean
Perpignan, France
Status: Recruiting
Start Date
May 2011
Completion Date
December 2014
Sponsors
AB Science
Source
AB Science
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page