NCT00866138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Feb 2005

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

5.9 years

First QC Date

March 19, 2009

Last Update Submit

December 2, 2019

Conditions

Multiple Myeloma

Keywords

multiple myelomat(4/14)relapsingrefractory

Outcome Measures

Primary Outcomes (1)

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

    16 weeks

Secondary Outcomes (2)

  • Tumor response rate with AB1010 plus dexamethasone

    16 weeks

  • Time to tumor progression and duration of response in responder patients

    16 weeks

Study Arms (1)

1

EXPERIMENTAL

masitinib (AB1010)

Drug: masitinib (AB1010)

Interventions

masitinib (AB1010)DRUG

masitinib 9 mg/kg/day per os

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Louis

Paris, France

Location

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Interventions

masitinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

February 1, 2005

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 3, 2019

Record last verified: 2019-12

Locations

FR(1)