Multiple MyelomaABE-DESCARTNCT06154902
Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in France.
Trial summary
The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Idecabtagene vicleucel and Not treated
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2022to 31 Dec 2027
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in France with RRMM who are eligible for treatment with, or have been treated with, idecabtagene vicleucel
Who may be able to join
- Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel
Who cannot join
- Not registered with the social security in France
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABE-DESCART Study: Characterization and Outcomes of Patients With Relapsed and Refractory Multiple Myeloma Eligible for Treatment or Treated With Abecma© (Idecabtagene Vicleucel) in Real World Setting in France. A Database Analysis Based on the DESCAR-T Registry
The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.
- Conditions
- Multiple Myeloma
- Being tested
- Idecabtagene vicleucel, Not treated
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idecabtagene vicleucelDrug
According to approved product label in France
Not treatedOther
Eligible for idecabtagene vicleucel treatment but not treated
| Study group | Role | What they receive |
|---|---|---|
| Treated with idecabtagene vicleucel | Not described Receives: Drug: Idecabtagene vicleucel | |
| Eligible for idecabtagene vicleucel | Eligible for idecabtagene vicleucel treatment but not treated Receives: Other: Not treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start29 Jul 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 350 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154902
- Sponsor's protocol ID
- CA089-1041
- Acronym
- ABE-DESCART
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABE-DESCART Study: Characterization and Outcomes of Patients With Relapsed and Refractory Multiple Myeloma Eligible for Treatment or Treated With Abecma© (Idecabtagene Vicleucel) in Real World Setting in France. A Database Analysis Based on the DESCAR-T Registry
- ClinicalTrials.gov ID
- NCT06154902
- Acronym / sponsor ID
- ABE-DESCART / CA089-1041
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Dec 2023 (actual)
- 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 this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with idecabtagene vicleucel | – | Drug: Idecabtagene vicleucel |
| Eligible for idecabtagene vicleucel | – | Other: Not treatedEligible for idecabtagene vicleucel treatment but not treated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in France with RRMM who are eligible for treatment with, or have been treated with, idecabtagene vicleucel
Key inclusion criteria (1 listed)
- Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel
Key exclusion criteria (1 listed)
- Not registered with the social security in France
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 |
|---|---|---|
| Idecabtagene vicleucelAccording to approved product label in France | Drug | Treated with idecabtagene vicleucel |
| Not treatedEligible for idecabtagene vicleucel treatment but not treated | Other | Eligible for idecabtagene vicleucel |
Primary outcome
Overall survival
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: 15 years). 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 4 Dec 2023.