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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: masitinib (AB1010)

• Registration Number: NCT00866138
• Lead Sponsor: AB Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	masitinib (AB1010)	masitinib (AB1010)

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG	16 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Saint Louis; 🇫🇷 Paris, France