Multiple MyelomaPhase 2NCT00866138
Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3
A Phase 2 study testing masitinib (AB1010) in people with Multiple Myeloma, run by AB Science at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- masitinib (AB1010)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2005to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Multiple Myeloma
- Being tested
- masitinib (AB1010)
- Keywords
- multiple myeloma, t(4/14), relapsing, refractory
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
masitinib (AB1010)Drug
masitinib 9 mg/kg/day per os
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | masitinib (AB1010) Receives: Drug: masitinib (AB1010) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG
Measured: 16 weeks
Secondary outcomes (2)
Tumor response rate with AB1010 plus dexamethasone
Measured: 16 weeks
Time to tumor progression and duration of response in responder patients
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startFeb 2005
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866138
- Sponsor's protocol ID
- AB04019
- Status last verified
- Dec 2019
- First submitted
- 19 Mar 2009
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00866138
- Acronym / sponsor ID
- AB04019
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, t(4/14), relapsing, refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Feb 2005 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: masitinib (AB1010)masitinib (AB1010) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| masitinib (AB1010)masitinib 9 mg/kg/day per os | Drug | 1 |
Primary outcome
Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG
Time frame: 16 weeks
2 secondary outcomes
Tumor response rate with AB1010 plus dexamethasone
Time frame: 16 weeks
Time to tumor progression and duration of response in responder patients
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing masitinib (AB1010) in people with Multiple Myeloma, run by AB Science at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.