[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569795":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":11,"studyPopulation":38,"armGroups":39,"interventions":44,"overallOfficials":50,"centralContacts":53,"locations":61,"responsibleParty":123,"collaborators":11,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":11,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":11,"enrollmentInfo":134,"targetDuration":11,"studyType":137,"phases":11,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Participant adverse events",null,"Monthly from months 4-18, every 2 months from months 19-59, and annually from month year 5 to 15",{"measure":14,"description":11,"timeFrame":15},"Number of participants with positive replication-competent lentivirus test results","At 4, 7, 13, and 25 months, and annually up to 15 years",{"measure":17,"description":11,"timeFrame":18},"Persistent vector sequence monitoring","Months 7-18 and annually from years 5-15",[20,23,26,29,31,33],{"measure":21,"description":11,"timeFrame":22},"Progression-free survival (PFS)","Monthly up to 18 months and every two months after month 19 up to 15 years",{"measure":24,"description":11,"timeFrame":25},"Overall survival (OS)","Every 3 months up to month 60, annually thereafter up to 15 years",{"measure":27,"description":11,"timeFrame":28},"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",{"measure":30,"description":11,"timeFrame":28},"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",{"measure":32,"description":11,"timeFrame":28},"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",{"measure":34,"description":11,"timeFrame":28},"Health-related quality of life (HRQoL) measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":36,"timePerspective":37,"maskingInfo":11},"COHORT","PROSPECTIVE","Adult participants with newly diagnosed multiple myeloma (NDMM) who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel in the KarMMa-9 (CA089-1043) Phase 3 clinical trial.",[40],{"label":41,"type":11,"description":11,"interventionNames":42},"Participants receiving idecabtagene vicleucel",[43],"Drug: Idecabtagene vicleucel",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"DRUG","Idecabtagene vicleucel","As per CA089-1043 study protocol",[41],[51],{"name":5,"affiliation":5,"role":52},"STUDY_DIRECTOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"BMS Study Connect Contact Center www.BMSStudyConnect.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":60,"role":56,"phone":11,"phoneExt":11,"email":11},"First line of the email MUST contain NCT # and Site #.",[62,79,93,103,113],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":11,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Chonnam National University Hwasun Hospital","RECRUITING","Hwasun","Jeonranamdo","58128","South Korea",{"type":70,"coordinates":71},"Point",[72,73],126.98746,35.06125,{"lat":73,"lon":72},[76],{"name":77,"role":56,"phone":78,"phoneExt":11,"email":11},"Sung Hoon Jung, Site 0041","82613797623",{"facility":80,"status":64,"city":81,"state":82,"zip":83,"country":68,"countryCode":11,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Seoul National University Hospital","Seoul","Seoul-teukbyeolsi [Seoul]","03080",{"type":70,"coordinates":85},[86,87],126.9784,37.566,{"lat":87,"lon":86},[90],{"name":91,"role":56,"phone":92,"phoneExt":11,"email":11},"SungSoo Yoon, Site 0039","82-2-2072-3079",{"facility":94,"status":64,"city":81,"state":82,"zip":95,"country":68,"countryCode":11,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Asan Medical Center","05505",{"type":70,"coordinates":97},[86,87],{"lat":87,"lon":86},[100],{"name":101,"role":56,"phone":102,"phoneExt":11,"email":11},"Dok Hyun Yoon, Site 0040","82230105940",{"facility":104,"status":64,"city":81,"state":82,"zip":105,"country":68,"countryCode":11,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Samsung Medical Center","06351",{"type":70,"coordinates":107},[86,87],{"lat":87,"lon":86},[110],{"name":111,"role":56,"phone":112,"phoneExt":11,"email":11},"Kihyun Kim, Site 0038","+821099333456",{"facility":114,"status":64,"city":81,"state":82,"zip":115,"country":68,"countryCode":11,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"The Catholic Univ. of Korea Seoul St. Mary's Hospital","06591",{"type":70,"coordinates":117},[86,87],{"lat":87,"lon":86},[120],{"name":121,"role":56,"phone":122,"phoneExt":11,"email":11},"Chang Ki Min, Site 0043","82-20-2258-6053",{"type":124,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100569795","a-study-to-evaluate-the-long-term-safety-of-idecabtagene-vicleucel-treatment-in-adults-with-newly-diagnosed-multiple-myeloma-in-korea-100569795",false,"NCT06698887","A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea","Long-Term Safety Follow-Up Surveillance for Phase 3 Trial (KarMMA-9\u002FCA089-1043) 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","Inclusion Criteria:\n\n* Adult participants ≥19 years of age\n* 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)\n* 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\n\nExclusion Criteria:\n\n* Participants who participate in KarMMa-9 trial (CA089-1043) but disagree with long-term follow-up surveillance in Korea\n* 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","ALL","18 Years",{"count":135,"type":136},15,"ESTIMATED","OBSERVATIONAL","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.",[140],"Multiple Myeloma",[140],"2026-09-30",{"date":144,"type":145},"2026-10-01","ACTUAL",{"date":147,"type":145},"2024-09-11",{"date":149,"type":136},"2031-03-27",{"name":5,"class":6},5]