Status:
COMPLETED
Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3
Lead Sponsor:
AB Science
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00866138
Start Date
February 1 2005
End Date
January 1 2011
Last Update
December 3 2019
Active Locations (1)
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1
Hopital Saint Louis
Paris, France