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

December 17, 2018 updated by: AB Science

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France
        • CHU Estaing
      • Corbeil-Essonnes, France
        • Centre Hospitalier Sud Francilien
      • Le Mans, France
        • CH Le Mans
      • Limoges, France
        • Hôpital Universitaire Dupuytren
      • Marseille, France
        • Hopital Ambroise Pare
      • Nantes, France
        • Hopital de l'Hotel Dieu
      • Paris, France
        • Hôpital Saint Louis
      • Perpignan, France
        • Centre Hospitalier Saint Jean
  • United States
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical and Surgical Specialists
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert & Medical College of Wisconsin-CLCC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Masitinib
Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
Drug: Masitinib
Masitinib 6 mg/kg/day
Other Names:
  • AB1010
Drug: Bortezomib
Standard therapy (cycles of bortezomib)
Other Names:
  • Velcade
Drug: Dexamethasone
Standard therapy (cycles of dexamethasone)
Other Names:
  • Dexasone
Placebo Comparator: Placebo
Placebo in combination with Bortezomib and Dexamethasone
Drug: Placebo
Matching placebo
Drug: Bortezomib
Standard therapy (cycles of bortezomib)
Other Names:
  • Velcade
Drug: Dexamethasone
Standard therapy (cycles of dexamethasone)
Other Names:
  • Dexasone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Investigators

  • Principal Investigator: Bertrand Arnulf, MD, Hôpital Saint-Louis, Paris - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB06002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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