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

October 25, 2011
December 12, 2012
May 2011
April 2013   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: Analysis to be conducted after a minimum of 201 events ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01470131 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: masitinib 6 mg/kg/day
    masitinib 6 mg/kg/day
    Other Name: masitinib 6 mg/kg/day with Bortezomib & Dexamethasone
  • Drug: placebo
    matching placebo
    Other Name: placebo in combination with Bortezomib and Dexamethasone
  • Experimental: masitinib 6 mg/kg/day
    masitinib in combination with Bortezomib and Dexamethasone
    Intervention: Drug: masitinib 6 mg/kg/day
  • Placebo Comparator: placebo
    placebo in combination with Bortezomib and Dexamethasone
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
April 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Bertrand Arnulf, MD bertrand.arnulf@sls.aphp.fr
United States,   France
 
NCT01470131
AB06002
Yes
AB Science
AB Science
Not Provided
Principal Investigator: Bertrand Arnulf, MD Hôpital Saint-Louis, Paris - France
AB Science
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP