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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00866138

Enrollment

Registered

2009-03-20

Start date

2005-02-28

Completion date

2011-01-31

Last updated

2019-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

multiple myeloma, t(4/14), relapsing, refractory

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.

Interventions

DRUGmasitinib (AB1010)

masitinib 9 mg/kg/day per os

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026