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

Sponsored by:	AB Science
Information provided by:	AB Science
ClinicalTrials.gov Identifier:	NCT00866138

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: masitinib (AB1010)	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by AB Science:

Primary Outcome Measures:

Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	24
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2010
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental masitinib (AB1010)	Drug: masitinib (AB1010) masitinib 9 mg/kg/day per os

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	AB Science ( Alain Moussy )
Study ID Numbers:	AB04019
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866138 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by AB Science:

multiple myeloma
t(4/14)
relapsing
refractory

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases

Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009