A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea
NCT ID: NCT06698887
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2024-09-11
2031-03-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants receiving idecabtagene vicleucel
Idecabtagene vicleucel
As per CA089-1043 study protocol
Interventions
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Idecabtagene vicleucel
As per CA089-1043 study protocol
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Sung Hoon Jung, Site 0041
Role: primary
SungSoo Yoon, Site 0039
Role: primary
Dok Hyun Yoon, Site 0040
Role: primary
Kihyun Kim, Site 0038
Role: primary
Chang Ki Min, Site 0043
Role: primary
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA089-1081
Identifier Type: -
Identifier Source: org_study_id