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

NCT01470131 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Masitinib

Masitinib 6 mg/kg/day

DRUG

Placebo

Matching placebo

DRUG

Bortezomib

Standard therapy (cycles of bortezomib)

DRUG

Dexamethasone

Standard therapy (cycles of dexamethasone)

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

  • Bertrand Arnulf, MD · Hôpital Saint-Louis, Paris - France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2017-01-04
Completion
2017-02-01
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01470131 on ClinicalTrials.gov