Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3

December 2, 2019 updated by: AB Science

Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3

This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

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
      • Paris, France
        • Hopital Saint Louis

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:

  • Confirmed multiple myeloma with a t (4; 14) translocation by FISH and PCR, expressing or not expressing FGFR3 identified by FACS
  • Patients with Multiple Myeloma progressing or relapsing after at least two prior therapies (including conventional chemotherapy and/or high dose therapy) or who get a reduction of M-protein less than 75% within 3 months after a high dose treatment (Melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to a conventional chemotherapy
  • Patient with rapidly progressive disease with cytopenia and / or renal failure have to be stabilized with chemotherapy (if possible 3 cycles of VTD ( Bortezomib/Thalidomide/dexamethasone) or high dose Melphalan regimen followed by a 4 weeks washout period before the inclusion in the study.
  • Patients must have a clearly detectable and quantifiable monoclonal M- component value (>5 g/l) in the serum and / or urine light chain excretion (>0,5 g/d)

Exclusion Criteria:

  • Prior corticosteroids within two weeks before enrolment
  • Prior local irradiation within two weeks before enrolment
  • Prior experimental or standard treatment (other than steroids and local irradiation) within 30 days before enrolment

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
masitinib (AB1010)
Drug: masitinib (AB1010)
masitinib 9 mg/kg/day per os

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response rate with AB1010 plus dexamethasone
Time Frame: 16 weeks
16 weeks
Time to tumor progression and duration of response in responder patients
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

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

Sponsor

AB Science

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)

February 1, 2005

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB04019

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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