Clinical trial NCT01470131: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: multiple myeloma
relapse
second line therapy
bortezomib
dexamethasone
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Progression Free Survival
timeFrame: Analysis to be conducted after a minimum of 201 events
Secondary outcomes:
measure: Overall Time to Progression
timeFrame: time from the date of randomization to the date of documented progression during the study
measure: Overall Survival
timeFrame: Until death
Other outcomes:
Locations:
city: Galesburg
country: United States
facility: Medical and Surgical Specialists
state: Illinois
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin-CLCC
state: Wisconsin
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Le Mans
country: France
facility: CH Le Mans
city: Limoges
country: France
facility: Hôpital Universitaire Dupuytren
city: Marseille
country: France
facility: Hôpital Ambroise Paré
city: Nantes
country: France
facility: Hôpital de l'Hôtel Dieu
city: Paris
country: France
facility: Hôpital Saint Louis
city: Perpignan
country: France
facility: Centre Hospitalier Saint Jean
Study officials:
affiliation: Hôpital Saint-Louis, Paris - France
name: Bertrand Arnulf, MD
role: PRINCIPAL_INVESTIGATOR
References: