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

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

masitinib (AB1010)

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, t(4/14), relapsing, refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Saint Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

masitinib (AB1010)

Outcomes

Primary Outcome Measures

Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG

Secondary Outcome Measures

Tumor response rate with AB1010 plus dexamethasone

Time to tumor progression and duration of response in responder patients

Full Information

NCT ID

NCT00866138

First Posted

March 19, 2009

Last Updated

December 2, 2019

Sponsor

AB Science

1. Study Identification

Unique Protocol Identification Number

NCT00866138

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

February 2005 (Actual)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AB Science

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

multiple myeloma, t(4/14), relapsing, refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

masitinib (AB1010)

Intervention Type

Drug

Intervention Name(s)

masitinib (AB1010)

Intervention Description

masitinib 9 mg/kg/day per os

Primary Outcome Measure Information:

Title

Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Tumor response rate with AB1010 plus dexamethasone

Time Frame

16 weeks

Title

Time to tumor progression and duration of response in responder patients

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hopital Saint Louis

City

Paris

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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