AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by AB Science.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

AB Science

ClinicalTrials.gov Identifier:

NCT00866138

First received: March 19, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 19, 2009
Last Updated Date	March 19, 2009
Start Date ^ICMJE	February 2005
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 19, 2009)	Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 19, 2009)	Tumor response rate with AB1010 plus dexamethasone [ Designated as safety issue: No ] Time to tumor progression and duration of response in responder patients [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3
Official Title ^ICMJE	Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: masitinib (AB1010) masitinib 9 mg/kg/day per os
Study Arm (s)	Experimental: 1 masitinib (AB1010) Intervention: Drug: masitinib (AB1010)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	24
Estimated Completion Date	December 2010
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00866138
Other Study ID Numbers ^ICMJE	AB04019
Has Data Monitoring Committee	No
Responsible Party	Alain Moussy, AB Science
Study Sponsor ^ICMJE	AB Science
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	AB Science
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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