A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
NCT ID: NCT01470131
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
147 participants
INTERVENTIONAL
2011-05-31
2017-02-01
Brief Summary
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Detailed Description
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Patients will receive study treatment (masitinib/placebo) with the standard therapy (bortezomib and dexamethazone).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Masitinib
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Masitinib
Masitinib 6 mg/kg/day
Bortezomib
Standard therapy (cycles of bortezomib)
Dexamethasone
Standard therapy (cycles of dexamethasone)
Placebo
Placebo in combination with Bortezomib and Dexamethasone
Placebo
Matching placebo
Bortezomib
Standard therapy (cycles of bortezomib)
Dexamethasone
Standard therapy (cycles of dexamethasone)
Interventions
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Masitinib
Masitinib 6 mg/kg/day
Placebo
Matching placebo
Bortezomib
Standard therapy (cycles of bortezomib)
Dexamethasone
Standard therapy (cycles of dexamethasone)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Bertrand Arnulf, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint-Louis, Paris - France
Locations
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Medical and Surgical Specialists
Galesburg, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Froedtert & Medical College of Wisconsin-CLCC
Milwaukee, Wisconsin, United States
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, , France
Countries
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Other Identifiers
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AB06002
Identifier Type: -
Identifier Source: org_study_id