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

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Idecabtagene vicleucel

• Registration Number: NCT06698887
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2031-03-27
• Study Completion: 2031-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving idecabtagene vicleucel	Idecabtagene vicleucel	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Monthly up to 18 months and every two months after month 19 up to 15 years
Overall survival (OS)	Every 3 months up to month 60, annually thereafter up to 15 years
Number of participants that achieve complete response or stringent complete response	At months 4-18, every 2 months from months 19-59, and annually from years 5-15
Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire	At months 4-18, every 2 months from months 19-59, and annually from years 5-15
Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer assessment of quality of life of myeloma patients (EORTC QLQ-MY20) questionnaire	At months 4-18, every 2 months from months 19-59, and annually from years 5-15
Health-related quality of life (HRQoL) measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire	At months 4-18, every 2 months from months 19-59, and annually from years 5-15

Trial Locations

Locations (5)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Jeonranamdo, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

The Catholic Univ. of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of