Status:
TERMINATED
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
Lead Sponsor:
AB Science
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01470131
Start Date
May 1 2011
End Date
February 1 2017
Last Update
December 19 2018
Active Locations (13)
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1
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
2
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
3
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
4
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534