[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590165":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":60,"collaborators":26,"id":64,"slug":26,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ASCT + CAR-T","EXPERIMENTAL","ASCT followed by BCMA CAR-T",[13,14],"Biological: autologous stem cell transplantation","Biological: CAR-T",{"label":16,"type":17,"description":18,"interventionNames":19},"ASCT alone","ACTIVE_COMPARATOR","ASCT alone, without CAR-T infusion",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","autologous stem cell transplantation","Patients in this arm will receive autologous hematopoietic stem cell transplantation (ASCT). Prior to ASCT, the patients underwent 3-4 cycles of induction chemotherapy.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"CAR-T","The T cells are genetically modified to express a chimeric antigen receptor targeting BCMA and are infused 3 days after ASCT at a target dose of ≥2.0×10\\^6 cells\u002Fkg.",[9],[32],{"name":33,"affiliation":34,"role":35},"Kailin Xu","The Affiliated Hospital oh Xuzhou Medical University","STUDY_CHAIR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","15162166166","lihmd@163.com",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":40},"+8615162166166",[44],{"facility":34,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Xuzhou","Jiangsu","221006","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.28386,34.20442,{"lat":54,"lon":53},[57,58],{"name":33,"role":38,"phone":42,"phoneExt":26,"email":40},{"name":59,"role":38,"phone":26,"phoneExt":26,"email":26},"Xu",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University","100590165",false,"NCT06963866","Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT","A Multicenter, Open-Label, Randomized, Controlled Study of Autologous Stem Cell Transplantation Followed by Anti-BCMA CAR-T Therapy Versus ASCT Alone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma","ASCTvsCAR-T","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Eligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.","ALL","18 Years","70 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.",[82],"Multiple Myeloma, Newly Diagnosed",[84,85,86,28],"Multiple Myeloma","Eligible for ASCT","ASCT","NOT_YET_RECRUITING","2025-04-30",{"date":90,"type":91},"2025-05-09","ACTUAL",{"date":93,"type":76},"2025-05-01",{"date":95,"type":76},"2028-04-30",{"name":5,"class":6},1]