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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01470131
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : November 11, 2011
Last Update Posted : December 17, 2018
Information provided by (Responsible Party):
AB Science

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: masitinib 6 mg/kg/day Drug: placebo Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2011
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : February 1, 2017

Arm Intervention/treatment
Experimental: masitinib 6 mg/kg/day
masitinib in combination with Bortezomib and Dexamethasone
Drug: masitinib 6 mg/kg/day
masitinib 6 mg/kg/day
Other Name: masitinib 6 mg/kg/day with Bortezomib & Dexamethasone

Placebo Comparator: placebo
placebo in combination with Bortezomib and Dexamethasone
Drug: placebo
matching placebo
Other Name: placebo in combination with Bortezomib and Dexamethasone

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Analysis to be conducted after a minimum of 201 events ]

Secondary Outcome Measures :
  1. Overall Time to Progression [ Time Frame: time from the date of randomization to the date of documented progression during the study ]
  2. Overall Survival [ Time Frame: Until death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient with confirmed multiple myeloma requiring systemic therapy. A
  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:

  1. Patient with peripheral neuropathy Grade >2
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01470131

United States, Illinois
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
United States, Wisconsin
Froedtert & Medical College of Wisconsin-CLCC
Milwaukee, Wisconsin, United States, 53226
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
Sponsors and Collaborators
AB Science
Principal Investigator: Bertrand Arnulf, MD Hôpital Saint-Louis, Paris - France

Responsible Party: AB Science Identifier: NCT01470131     History of Changes
Other Study ID Numbers: AB06002
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AB Science:
multiple myeloma
second line therapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors