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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470131

Enrollment

147

Registered

2011-11-11

Start date

2011-05-31

Completion date

2017-02-01

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone

Brief summary

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.

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).

Interventions

DRUGMasitinib

Masitinib 6 mg/kg/day

DRUGPlacebo

Matching placebo

DRUGBortezomib

Standard therapy (cycles of bortezomib)

DRUGDexamethasone

Standard therapy (cycles of dexamethasone)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient with confirmed multiple myeloma requiring systemic therapy. A 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

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)

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	Analysis to be conducted after a minimum of 201 events

Secondary

Measure	Time frame
Overall Time to Progression	time from the date of randomization to the date of documented progression during the study
Overall Survival	Until death

Countries

France, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026