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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by AB Science.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
AB Science Identifier:
First received: October 25, 2011
Last updated: December 12, 2012
Last verified: December 2012
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 Intervention Phase
Multiple Myeloma
Drug: masitinib 6 mg/kg/day
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by AB Science:

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

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

Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).


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

Inclusion Criteria:

  1. Patient with confirmed multiple myeloma requiring systemic therapy. All three criteria must be met:

    • Clonal bone marrow plasma cells > 10%
    • Presence of serum and/or urinary monoclonal protein
    • Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:

      • Hypercalcemia: serum calcium > 11.5 mg/100 ml or
      • Renal insufficiency: serum creatinine > 173 µmol/l
      • Anemia: normochromic, normocytic with a hemoglobin value of > 2g/100 ml below the lower limit of normal or a hemoglobin value < 10g/100 ml
      • Bone lesions: lytic lesions, severe osteopenia or pathologic fractures
  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 defined by at least one of the following two measurements:

    • Serum M-protein ≥ 1 g/dL
    • Urine M-protein ≥ 200 mg/24h

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01470131

Contact: Bertrand Arnulf, MD

United States, Illinois
Medical and Surgical Specialists Recruiting
Galesburg, Illinois, United States, 61401
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Southeastern Medical Oncology Center Recruiting
Goldsboro, North Carolina, United States, 27534
United States, Wisconsin
Froedtert & Medical College of Wisconsin-CLCC Recruiting
Milwaukee, Wisconsin, United States, 53226
CHU Estaing Recruiting
Clermont Ferrand, France
Centre Hospitalier Sud Francilien Recruiting
Corbeil Essonne, France
CH Le Mans Recruiting
Le Mans, France
Hôpital Universitaire Dupuytren Recruiting
Limoges, France
Hôpital Ambroise Paré Recruiting
Marseille, France
Hôpital de l'Hôtel Dieu Recruiting
Nantes, France
Hôpital Saint Louis Recruiting
Paris, France
Centre Hospitalier Saint Jean Recruiting
Perpignan, France
Sponsors and Collaborators
AB Science
Principal Investigator: Bertrand Arnulf, MD Hôpital Saint-Louis, Paris - France
  More Information

Responsible Party: AB Science Identifier: NCT01470131     History of Changes
Other Study ID Numbers: AB06002
Study First Received: October 25, 2011
Last Updated: December 12, 2012

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
Dexamethasone 21-phosphate
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 processed this record on March 28, 2017