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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866138
• Other study ID #: AB04019
• Status: Completed
• Phase: Phase 2
• Start date: February 2005
• Est. completion date: January 2011

Study information

• Verified date: December 2019
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• masitinib (AB1010)
masitinib 9 mg/kg/day per os

Locations

Country	Name	City	State
France	Hopital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG		16 weeks
Secondary	Tumor response rate with AB1010 plus dexamethasone		16 weeks
Secondary	Time to tumor progression and duration of response in responder patients		16 weeks