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

Part of paid clinical trials in Galesburg, Illinois.

Sponsor
AB Science
Study ID
NCT01470131
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Masitinib — DRUG
    Masitinib 6 mg/kg/day
  • Placebo — DRUG
    Matching placebo
  • Bortezomib — DRUG
    Standard therapy (cycles of bortezomib)
  • Dexamethasone — DRUG
    Standard therapy (cycles of dexamethasone)

Study Details

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.

Key Dates

Start date
May 31, 2011
Status verified
Dec 2018
Primary completion
Jan 4, 2017
Completion
Feb 1, 2017

Study Design

Enrollment
147 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Masitinib
    Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
  • Placebo Comparator: Placebo
    Placebo in combination with Bortezomib and Dexamethasone

Primary Outcome Measure

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

Locations (5)

FacilityCityStateZIPSite coordinators
Medical and Surgical SpecialistsGalesburgIllinois61401-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27534-
Froedtert & Medical College of Wisconsin-CLCCMilwaukeeWisconsin53226-

Find similar trials in Galesburg, IL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Medical and Surgical Specialists· Galesburg, ILCenter for Cancer and Blood Disorders· Bethesda, MDCarolinas Medical Center· Charlotte, NCSoutheastern Medical Oncology Center· Goldsboro, NCFroedtert & Medical College of Wisconsin-CLCC· Milwaukee, WI

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