Multiple MyelomaPhase 3NCT01470131
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
A Phase 3 study testing Masitinib, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by AB Science at 13 sites in 2 countries.
Trial summary
The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy. 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, Bortezomib and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 13 sitesin 2 countries
- Study dates
- May 2011to 1 Feb 2017
- Phase
- Phase 3
- 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
- Patient with confirmed multiple myeloma requiring systemic therapy. A
- Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) to one previous line of treatment
- Patient with measurable progressive disease
Who cannot join
- Patient with peripheral neuropathy Grade >2
- Patient with hypersensitivity to bortezomib, boron or dexamethasone
- Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
- Patient who received bortezomib within 6 months of randomization to this study
- Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
- Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
France8 sites
CHU Estaing
Clermont-Ferrand
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
CH Le Mans
Le Mans
Hôpital Universitaire Dupuytren
Limoges
Hôpital Ambroise Paré
Marseille
Hôpital de l'Hôtel Dieu
Nantes
Hôpital Saint Louis
Paris
Centre Hospitalier Saint Jean
Perpignan
United States5 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Carolinas Medical Center
Charlotte, North Carolina, 28203
Medical and Surgical Specialists
Galesburg, Illinois, 61401
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
Froedtert & Medical College of Wisconsin-CLCC
Milwaukee, Wisconsin, 53226
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy
The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.
Read the detailed description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day to placebo in the treatment of patients with relapsing multiple myeloma who received one previous therapy.
Patients will receive study treatment (masitinib/placebo) with the standard therapy (bortezomib and dexamethazone).
- Conditions
- Multiple Myeloma
- Being tested
- Masitinib, Placebo, Bortezomib, Dexamethasone
- Keywords
- multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone
- 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.
MasitinibDrug
Also called AB1010
Masitinib 6 mg/kg/day
PlaceboDrug
Matching placebo
BortezomibDrug
Also called Velcade
Standard therapy (cycles of bortezomib)
DexamethasoneDrug
Also called Dexasone
Standard therapy (cycles of dexamethasone)
| Study group | Role | What they receive |
|---|---|---|
| Masitinib | Experimental | Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone Receives: Drug: Masitinib; Drug: Bortezomib; Drug: Dexamethasone |
| Placebo | Placebo comparator | Placebo in combination with Bortezomib and Dexamethasone Receives: Drug: Placebo; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Analysis to be conducted after a minimum of 201 events
Secondary outcomes (2)
Overall Time to Progression
Measured: time from the date of randomization to the date of documented progression during the study
Overall Survival
Measured: Until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startMay 2011
- Primary completion4 Jan 2017
- Study completion1 Feb 2017
Why it stopped: Sponsor decision based on portfolio prioritization
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bertrand Arnulf, MD, Principal investigator, Hôpital Saint-Louis, Paris - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470131
- Sponsor's protocol ID
- AB06002
- Status last verified
- Dec 2018
- First submitted
- 25 Oct 2011
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy
- ClinicalTrials.gov ID
- NCT01470131
- Acronym / sponsor ID
- AB06002
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, relapse, second line therapy, bortezomib, dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 147 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- May 2011 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 11 Nov 2011 (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.
The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.
Detailed description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day to placebo in the treatment of patients with relapsing multiple myeloma who received one previous therapy.
Patients will receive study treatment (masitinib/placebo) with the standard therapy (bortezomib and dexamethazone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masitinib | Experimental | Drug: Masitinib, Drug: Bortezomib, Drug: DexamethasoneMasitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Bortezomib, Drug: DexamethasonePlacebo in combination with Bortezomib and Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with confirmed multiple myeloma requiring systemic therapy. A
- Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) to one previous line of treatment
- Patient with measurable progressive disease
Key exclusion criteria (6 listed)
- Patient with peripheral neuropathy Grade >2
- Patient with hypersensitivity to bortezomib, boron or dexamethasone
- Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy
- Patient who received bortezomib within 6 months of randomization to this study
- Past discontinuation of bortezomib due to associated grade 3 or higher adverse event
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 |
|---|---|---|
| MasitinibAlso: AB1010Masitinib 6 mg/kg/day | Drug | Masitinib |
| PlaceboMatching placebo | Drug | Placebo |
| BortezomibAlso: VelcadeStandard therapy (cycles of bortezomib) | Drug | Masitinib, Placebo |
| DexamethasoneAlso: DexasoneStandard therapy (cycles of dexamethasone) | Drug | Masitinib, Placebo |
Primary outcome
Progression Free Survival
Time frame: Analysis to be conducted after a minimum of 201 events
2 secondary outcomes
Overall Time to Progression
Time frame: time from the date of randomization to the date of documented progression during the study
Overall Survival
Time frame: Until death
Results and safety
The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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.
Bertrand Arnulf, MD principal investigator
Hôpital Saint-Louis, Paris - France
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by AB Science at 13 sites in 2 countries.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
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?
Progression Free Survival (time frame: Analysis to be conducted after a minimum of 201 events). 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 19 Dec 2018.