A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea

Recruiting now

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06698887

Run by

Bristol-Myers Squibb

People needed

15

Starts

2024-09-11

Expected to finish

2031-03-27

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chonnam National University Hwasun Hospital — Hwasun, Jeonranamdo, South Korea (enrolling)
• Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (enrolling)
• Asan Medical Center — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (enrolling)
• Samsung Medical Center — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (enrolling)
• The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (enrolling)

Full record on ClinicalTrials.gov

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