[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551717":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":65,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":87,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ASCT regimen",null,"Primary multiple myeloma patients who receive autologous hematopoietic stem-cell transplantation (ASCT) after they achieved MRD negativity after induction",[13],"Drug: Transplant, Autologous",{"label":15,"type":10,"description":16,"interventionNames":17},"non ASCT regimen","Primary multiple myeloma patients who receive non autologous hematopoietic stem-cell transplantation (ASCT) regimen such as 4-6 cycles of bortezomib-lenalidomide-dexamethasone after they achieved MRD negativity after induction",[18],"Drug: Chemotherapy drug",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Transplant, Autologous","High-dose melphalan followed by autologous stem cell transplantation",[9],[26],"ASCT",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Chemotherapy drug","Regimen such as Bortezomib plus Lenalidomide plus Dexamethasone",[15],[32],"Non ASCT regimen",[34],{"name":35,"affiliation":36,"role":37},"Haitao Meng","Zhejiang University","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Liangshun You","CONTACT","+86 15088687797","youliangshun@zju.edu.cn",{"name":45,"role":41,"phone":46,"phoneExt":10,"email":47},"Qiumei Yao","+86 13867490514","qiumei_yao@163.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The First Affiliated Hospital of Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":58,"coordinates":59},"Point",[60,61],120.16142,30.29365,{"lat":61,"lon":60},[64],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68,70,72],{"name":69,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":71,"class":6},"The Affiliated Hospital of Medical College, Ningbo University",{"name":73,"class":6},"Dongyang People's Hospital","100551717","primary-multiple-myeloma-who-achieved-mrd-negativity-after-induction-therapy-asct-or-not-100551717",false,"NCT06463717","Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not","Comparing the Efficacy and Safety of Autologous Hematopoietic Stem-cell Transplantation Versus Non Transplantation Regimen in Primary Multiple Myeloma Achieved MRD Negativity After Induction: A Multiple Center, Prospective Cohort Study","Inclusion Criteria:\n\n1. Newly diagnosed multiple myeloma according to the criteria of International Working Group of Myeloma\n2. Age ranges from 18-70 years old\n3. Achieved MRD negativity and at least very good partial response in clinical response after 4-6 courses of induction therapy. MRD is measured by MRD by multicolor flow with a sensitivity of 10-5.\n4. At enrollment, score of Eastern Cooperative Oncology Group (ECOG) should be 0-2.\n5. Organ function requirement: Blood bilirubin ≤ 2mg\u002FdL (35 μ mol\u002FL), Alanine aminotransferase\u002FAspartate aminotransferase below 2 times the upper limit of normal value, Creatinine clearance rate (Ccr) ≥ 30ml\u002Fmin and Cardiac ejection fraction ≥50%.\n6. Expected survival more than 3 months.\n\nExclusion Criteria:\n\n1. Two or more high-risk cytogenetic abnormalities, including del (17p), t (4; 14), t (14; 16), del (1p), amp (1q). Fluorescence in situ hybridization was used to analyze CD138 positive sorted cells, with cut off value of 15% for translocation, 10% for deletion, and amp (1q) of 20%.\n2. Extracellular plasma cell disease, central invasion of myeloma, plasma cell leukemia\n3. History of other malignant tumors within the past 5 years\n4. Patients with HIV, active tuberculosis, clinically active hepatitis A, B, or C\n5. Other serious condition that may restrict patients from continuing treatment (such as advanced infection, uncontrolled diabetes, severe cardiac insufficiency, or angina pectoris)\n6. General condition not suitable for chemotherapy\n7. Pregnant or lactating women\n8. Suffering from other serious organic diseases and mental disorders.","ALL","18 Years","70 Years",{"count":85,"type":86},210,"ESTIMATED","2 Years","OBSERVATIONAL","The goal of this observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction.\n\nThe main question it aims to answer is:\n\nIn primary multiple myeloma patients who achieved MRD negativity after induction, non ASCT regimens are not inferior to ASCT or not? Participants will receive ASCT or non ASCT regimen according to their own choice.\n\nResearchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety.",[91,92],"Multiple Myeloma","Minimal Residual Disease",[94,95],"Minimal Residual Disease Negativity","Autologous Stem Cell Transplantation","2024-06-21",{"date":98,"type":99},"2024-06-24","ACTUAL",{"date":101,"type":99},"2023-12-01",{"date":103,"type":86},"2028-12",{"name":5,"class":6},1]