Monitoring long-term safety of idecabtagene vicleucel in newly diagnosed multiple myeloma patients in Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the long-term safety of idecabtagene vicleucel treatment in adults with newly diagnosed multiple myeloma who previously participated in the KarMMa-9 clinical trial. Participants will be monitored for safety outcomes following their treatment. The study focuses on individuals who had a suboptimal response after autologous stem cell transplantation. It is an observational study that will collect data on the long-term effects of the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.