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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01470131
• Other study ID #: AB06002
• Status: Terminated
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: February 1, 2017

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 147
• Est. completion date: February 1, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Masitinib
Masitinib 6 mg/kg/day
• Placebo
Matching placebo
• Bortezomib
Standard therapy (cycles of bortezomib)
• Dexamethasone
Standard therapy (cycles of dexamethasone)

Locations

Country	Name	City	State
France	CHU Estaing	Clermont Ferrand
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	CH Le Mans	Le Mans
France	Hôpital Universitaire Dupuytren	Limoges
France	Hôpital Ambroise Paré	Marseille
France	Hôpital de l'Hôtel Dieu	Nantes
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier Saint Jean	Perpignan
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Medical and Surgical Specialists	Galesburg	Illinois
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Froedtert & Medical College of Wisconsin-CLCC	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		Analysis to be conducted after a minimum of 201 events
Secondary	Overall Time to Progression		time from the date of randomization to the date of documented progression during the study
Secondary	Overall Survival		Until death