This trial is active, not recruiting.

Condition multiple myeloma
Treatment masitinib (ab1010)
Phase phase 2
Sponsor AB Science
Start date February 2005
End date January 2011
Trial size 24 participants
Trial identifier NCT00866138, AB04019


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
masitinib (AB1010)
masitinib (ab1010)
masitinib 9 mg/kg/day per os

Primary Outcomes

Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG
time frame: 16 weeks

Secondary Outcomes

Tumor response rate with AB1010 plus dexamethasone
time frame: 16 weeks
Time to tumor progression and duration of response in responder patients
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Life expectancy > 3 months - 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) - ECOG = 0 -2 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 - Contra-indication to high dose steroids (including ongoing active infection) - Patient treated for a cancer other than MM within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by AB Science.