Multiple Myeloma Clinical Trial

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

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.

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Full 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).

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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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

147

Study ID:

NCT01470131

Recruitment Status:

Terminated

Sponsor:

AB Science

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There are 5 Locations for this study

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Medical and Surgical Specialists
Galesburg Illinois, 61401, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Froedtert & Medical College of Wisconsin-CLCC
Milwaukee Wisconsin, 53226, 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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

147

Study ID:

NCT01470131

Recruitment Status:

Terminated

Sponsor:


AB Science

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