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Completed

NCT Number: NCT00866138

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Saint Louis

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

masitinib (AB1010)

Drug

masitinib 9 mg/kg/day per os

Primary outcomes

  1. Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG

    Time frame: 16 weeks

Secondary outcomes

  1. Tumor response rate with AB1010 plus dexamethasone

    Time frame: 16 weeks

  2. Time to tumor progression and duration of response in responder patients

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 20, 2009
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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