Clinical trial · Interventional
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
NCT00866138CI-TRIAL-00042042completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| masitinib (AB1010) | Drug | Masitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- masitinib (AB1010)
- interventionNames
- Drug: masitinib (AB1010)
Primary outcomes (1)
- measure
- Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG
- timeFrame
- 16 weeks
Secondary outcomes (2)
- measure
- Tumor response rate with AB1010 plus dexamethasone
- timeFrame
- 16 weeks
- measure
- Time to tumor progression and duration of response in responder patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.