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

Plain Language Summary

Simplified for easier understanding

This is a long-term safety follow-up study for Korean patients with multiple myeloma (a blood cancer of plasma cells) who were already treated with a CAR-T cell therapy called idecabtagene vicleucel (ide-cel) in a previous clinical trial (KarMMa-9), monitoring their health outcomes over time. **You may be eligible if...** - You are 19 years or older - You are a Korean participant who received ide-cel treatment in the KarMMa-9 clinical trial - You are willing to sign the informed consent for this long-term follow-up study **You may NOT be eligible if...** - You participated in KarMMa-9 but do not agree to long-term follow-up surveillance in Korea - Your health status makes continued follow-up not feasible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIdecabtagene vicleucel

As per CA089-1043 study protocol


Locations(5)

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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NCT06698887


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