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

NCT06698887 · tracked via the Priya Life Science South Korea tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2024-09-11

Last updated

2026-10-01

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Idecabtagene vicleucel →

Idecabtagene vicleucel: As per CA089-1043 study protocol

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Participant adverse events — Monthly from months 4-18, every 2 months from months 19-59, and annually from month year 5 to 15
Number of participants with positive replication-competent lentivirus test results — At 4, 7, 13, and 25 months, and annually up to 15 years
Persistent vector sequence monitoring — Months 7-18 and annually from years 5-15

Trial sites (5)

Facility	City	Region	Status
Chonnam National University Hwasun Hospital	Hwasun	Jeonranamdo	Recruiting
Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Recruiting
Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]	Recruiting
Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]	Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Recruiting

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Other trials for the same condition

A Study 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 Active, not recruiting

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting

Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma Active, not recruiting

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM Active, not recruiting

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06698887 on ClinicalTrials.gov ↗ ← All trials in South Korea