[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598395":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":29,"responsibleParty":42,"collaborators":29,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":29,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":69,"whyStopped":29,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":29},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ASCT","ACTIVE_COMPARATOR","ASCT alone",[13],"Biological: ASCT",{"label":15,"type":16,"description":17,"interventionNames":18},"CAR-T","EXPERIMENTAL","CAR-T alone",[19],"Biological: CAR-T",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","The T cells are genetically modified to expressa chimeric antigen receptor targeting BCMA andare infused after induction therapy at a target dose of ≥2.0×10\\^6 cells\u002Fkg",[15],[17],{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Patients in this arm will receive autologous hematopoietic stem cell transplantation (ASCT).",[9],null,[31],{"name":32,"affiliation":33,"role":34},"Kailin Xu","The Affiliated Hospital oh Xuzhou Medical University","STUDY_CHAIR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},"CONTACT","+8615162166166","lihmd@163.com",{"name":32,"role":37,"phone":41,"phoneExt":29,"email":39},"15162166166",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University","100598395","phase-2-car-t-vs-auto-sct-which-works-better-for-new-myeloma-patients-100598395",false,"NCT07070934","CAR-T vs. Auto-SCT: Which Works Better for New Myeloma Patients?","A Multicenter, Open-label, Randomized Controlled Trial Comparing Anti-BCMA CAR-T Cell Therapy Versus Autologous Hematopoietic Stem Cell Transplantation 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":58,"type":59},60,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is a prospective study comparing anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.",[65,66],"Multiple Myeloma","Newly Diagnosed",[65,68,9,15],"Eligible for ASCT","NOT_YET_RECRUITING","2025-07-08",{"date":72,"type":73},"2025-07-17","ACTUAL",{"date":75,"type":59},"2025-07-15",{"date":77,"type":59},"2028-07-31",{"name":5,"class":6}]