RecruitingNCT06698887
A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea
Long-Term Safety Follow-Up Surveillance for Phase 3 Trial (KarMMA-9/CA089-1043) to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
Sponsor
Bristol-Myers Squibb
Enrollment
15 participants
Start Date
Sep 11, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Adult participants ≥19 years of age
- Korean participants with newly diagnosed multiple myeloma who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel (assigned to Arm A) in the KarMMa-9 trial (CA089-1043)
- Participants must understand and voluntarily sign and informed consent form (ICF) for the Korea long-term follow-up surveillance study prior to any surveillance-related procedures being conducted
Exclusion Criteria2
- Participants who participate in KarMMa-9 trial (CA089-1043) but disagree with long-term follow-up surveillance in Korea
- Participants who are not possible to treat with Ide-cel within 9 days post-completion of lymphodepleting chemotherapy (LDC), if delays occur. However, depending on the participants recovery status, whether idecabtagene vicleucel is administered or not, should be discussed with a medical monitor
Interventions
DRUGIdecabtagene vicleucel
As per CA089-1043 study protocol
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06698887
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