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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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).


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

Analysis to be conducted after a minimum of 201 events

Safety Issue:

No

Principal Investigator

Bertrand Arnulf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Saint-Louis, Paris - France

Authority:

United States: Food and Drug Administration

Study ID:

AB06002

NCT ID:

NCT01470131

Start Date:

May 2011

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • relapse
  • second line therapy
  • bortezomib
  • dexamethasone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Medical and Surgical SpecialistsGalesburg, Illinois  61401
Froedtert & Medical College of Wisconsin-CLCCMilwaukee, Wisconsin  53226