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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01470131
First received: October 25, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Time to Progression [ Time Frame: time from the date of randomization to the date of documented progression during the study ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Until death ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01470131

Contacts
Contact: Bertrand Arnulf, MD bertrand.arnulf@sls.aphp.fr

Locations
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
France
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
Investigators
Principal Investigator: Bertrand Arnulf, MD Hôpital Saint-Louis, Paris - France
  More Information

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01470131     History of Changes
Other Study ID Numbers: AB06002
Study First Received: October 25, 2011
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Czech Republic: State Institute for Drug Control

Keywords provided by AB Science:
multiple myeloma
relapse
second line therapy
bortezomib
dexamethasone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on September 18, 2014