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

NCT01470131 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: AB06002
• Study Type: interventional
• Target: 147
• Locations: 2 countries
• Sites: 13

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.

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Analysis to be conducted after a minimum of 201 events

Secondary Outcomes (2)

• Overall Time to Progression

  time from the date of randomization to the date of documented progression during the study

• Overall Survival

  Until death

Study Arms (2)

Masitinib

EXPERIMENTAL

Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone

Drug: Masitinib; Drug: Bortezomib; Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo in combination with Bortezomib and Dexamethasone

Drug: Placebo; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Masitinib DRUG

Masitinib 6 mg/kg/day

Also known as: AB1010

Masitinib

Placebo DRUG

Matching placebo

Placebo

Bortezomib DRUG

Standard therapy (cycles of bortezomib)

Also known as: Velcade

Masitinib; Placebo

Dexamethasone DRUG

Standard therapy (cycles of dexamethasone)

Also known as: Dexasone

Masitinib; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with confirmed multiple myeloma requiring systemic therapy. A
• 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
• Patient with measurable progressive disease

You may not qualify if:

• Patient with peripheral neuropathy Grade \>2
• Patient with hypersensitivity to bortezomib, boron or dexamethasone
• Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
• Patient who received bortezomib within 6 months of randomization to this study
• Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
• 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)

Sponsors & Collaborators

• AB Science: lead

Study Sites (13)

Medical and Surgical Specialists

Galesburg, Illinois, 61401, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Froedtert & Medical College of Wisconsin-CLCC

Milwaukee, Wisconsin, 53226, United States

Location

CHU Estaing

Clermont-Ferrand, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

CH Le Mans

Le Mans, France

Location

Hôpital Universitaire Dupuytren

Limoges, France

Location

Hôpital Ambroise Paré

Marseille, France

Location

Hôpital de l'Hôtel Dieu

Nantes, France

Location

Hôpital Saint Louis

Paris, France

Location

Centre Hospitalier Saint Jean

Perpignan, France

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

masitinib; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bertrand Arnulf, MD

  Hôpital Saint-Louis, Paris - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 11, 2011
• Study Start: May 1, 2011
• Primary Completion: January 4, 2017
• Study Completion: February 1, 2017
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

FR (8); US (5)