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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01470131

Run by

AB Science

People needed

147

Starts

2011-05-01

Expected to finish

2017-02-01

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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