ABE-DESCART: Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06154902
Collaborator
(none)
350
1
65.1
5.4
Study Details
Study Description
Brief 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. This study will use both prospective and retrospective data from the DESCAR-T registry database.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
350 participants
Observational Model:
Cohort
Time Perspective:
Other
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
Actual Study Start Date
:
Jul 29, 2022
Anticipated Primary Completion Date
:
Jul 31, 2027
Anticipated Study Completion Date
:
Dec 31, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treated with idecabtagene vicleucel
|
Drug: Idecabtagene vicleucel
According to approved product label in France
|
| Eligible for idecabtagene vicleucel Eligible for idecabtagene vicleucel treatment but not treated |
Other: Not treated
Eligible for idecabtagene vicleucel treatment but not treated
|
Outcome Measures
Primary Outcome Measures
- Overall survival [15 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel
Exclusion Criteria:
- Not registered with the social security in France
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DESCAR-T Registry | Paris | France |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT06154902
Other Study ID Numbers:
- CA089-1041
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: