Back to resultsA Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Placebo
Bortezomib
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone
Eligibility Criteria
Inclusion Criteria:
- Patient with confirmed multiple myeloma requiring systemic therapy. A
- 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
- Patient with measurable progressive disease
Exclusion Criteria:
- Patient with peripheral neuropathy Grade >2
- Patient with hypersensitivity to bortezomib, boron or dexamethasone
- Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
- Patient who received bortezomib within 6 months of randomization to this study
- Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
- 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)
Sites / Locations
- Medical and Surgical Specialists
- Center for Cancer and Blood Disorders
- Carolinas Medical Center
- Southeastern Medical Oncology Center
- Froedtert & Medical College of Wisconsin-CLCC
- CHU Estaing
- Centre Hospitalier Sud Francilien
- CH Le Mans
- Hôpital Universitaire Dupuytren
- Hôpital Ambroise Paré
- Hôpital de l'Hôtel Dieu
- Hôpital Saint Louis
- Centre Hospitalier Saint Jean
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Masitinib
Placebo
Arm Description
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Placebo in combination with Bortezomib and Dexamethasone
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Overall Time to Progression
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01470131
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
May 2011 (Actual)
Primary Completion Date
January 4, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib
Arm Type
Experimental
Arm Description
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with Bortezomib and Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Description
Masitinib 6 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
Standard therapy (cycles of bortezomib)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexasone
Intervention Description
Standard therapy (cycles of dexamethasone)
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Analysis to be conducted after a minimum of 201 events
Secondary Outcome Measure Information:
Title
Overall Time to Progression
Time Frame
time from the date of randomization to the date of documented progression during the study
Title
Overall Survival
Time Frame
Until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with confirmed multiple myeloma requiring systemic therapy. A
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
Patient with measurable progressive disease
Exclusion Criteria:
Patient with peripheral neuropathy Grade >2
Patient with hypersensitivity to bortezomib, boron or dexamethasone
Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
Patient who received bortezomib within 6 months of randomization to this study
Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Arnulf, MD
Organizational Affiliation
Hôpital Saint-Louis, Paris - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical and Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Froedtert & Medical College of Wisconsin-CLCC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
CHU Estaing
City
Clermont Ferrand
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
Country
France
Facility Name
CH Le Mans
City
Le Mans
Country
France
Facility Name
Hôpital Universitaire Dupuytren
City
Limoges
Country
France
Facility Name
Hôpital Ambroise Paré
City
Marseille
Country
France
Facility Name
Hôpital de l'Hôtel Dieu
City
Nantes
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Centre Hospitalier Saint Jean
City
Perpignan
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
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