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

Sponsor

AB Science (Industry)

Overall Status

Completed

CT.gov ID

NCT00866138

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: masitinib (AB1010)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

masitinib (AB1010)

Drug: masitinib (AB1010)

masitinib 9 mg/kg/day per os

Outcome Measures

Primary Outcome Measures

Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG [16 weeks]

Secondary Outcome Measures

Tumor response rate with AB1010 plus dexamethasone [16 weeks]
Time to tumor progression and duration of response in responder patients [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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