[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583673":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":80,"collaborators":18,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":18,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":18,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KPD consolidation","EXPERIMENTAL","KPD consolidation therapy for 2 cycles, followed by maintenance",[13],"Drug: KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation",{"label":15,"type":16,"description":17,"interventionNames":18},"No consolidation","NO_INTERVENTION","Direct maintenance without consolidation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation","After post-transplant randomization, patients will receive either KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation then maintenance or no consolidation and maintenance.",[9],[26],{"name":27,"affiliation":5,"role":28},"Jin Lu, M.D.","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Xuelin Dou, M.D.","CONTACT","+86-010-8649-1513","dxldw@163.com",[36,56,67],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50,54],{"name":51,"role":32,"phone":52,"phoneExt":53,"email":34},"Xuelin Dou","+86-010-82816999","7003",{"name":55,"role":28,"phone":18,"phoneExt":18,"email":18},"Jin Lu",{"facility":57,"status":37,"city":38,"state":39,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Fuxing Hospital affiliated to Capital Medical University","100045",{"type":44,"coordinates":60},[46,47],{"lat":47,"lon":46},[63],{"name":64,"role":32,"phone":65,"phoneExt":18,"email":66},"Liru Wang","86-18618238625","wanglirumail@126.com",{"facility":68,"status":37,"city":69,"state":70,"zip":71,"country":41,"countryCode":42,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Shanghai Changzheng Hospital","Shanghai","Shanghai Municipality","021",{"type":44,"coordinates":73},[74,75],121.45806,31.22222,{"lat":75,"lon":74},[78],{"name":79,"role":32,"phone":18,"phoneExt":18,"email":18},"Wanting Qiang",{"type":28,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jin Lu, MD","Deputy Director of Department of Hematology","100583673","phase-2-kpd-consolidation-after-asct-in-ndmm-patients-100583673",false,"NCT06879379","KPD Consolidation After ASCT in NDMM Patients","A Randomized, Multicenter Study Comparing Post-Transplant KPD Regimen Consolidation With No Consolidation in Newly Diagnosed Multiple Myeloma (NDMM) Transplant-eligible Patients","Inclusion Criteria:\n\n* Age ≥18 years.\n* Newly diagnosed MM eligible for transplantation.\n* Received upfront triplet or quadraplet induction regimen.\n* Received upfront ASCT after induction.\n* ECOG score \\\u003C 2.\n* Adequate Organ Function Reserve:\n\n  1. Alanine aminotransferase (ALT) \u002F Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);\n  2. Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;\n  3. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;\n  4. Basal oxygen saturation \\> 95% in room air;\n* Women of childbearing age agree to use effective contraceptive measures during the period of using the study drug and within 3 months after the last administration of the study drug; and to use highly effective contraceptive measures for at least 1 year thereafter. Male participants with fertile partners must agree to use effective barrier contraception during the period of using the study drug and within 3 months after the last administration of the study drug;\n* The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.\n\nExclusion Criteria:\n\n* Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);\n* Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;\n* Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures, cerebral vascular ischemia\u002F hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the CNS;\n* Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrow failure syndrome;\n* Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another malignancy with evidence of residual disease (excluding patients with any type of non-melanoma skin cancer or completely resected carcinoma in situ);\n* Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;\n* Patients known to be allergic to any of the study drugs, their analogs, or any excipients of the study drugs in various formulations;\n* Patients with concurrent or suspected central nervous system infiltration;\n* Patients with drug use, medical, psychological, or social conditions that may interfere with the participant's ability to participate in the study or the assessment of study outcomes;\n* Pregnant or lactating women;\n* Any other conditions deemed by the investigator as unsuitable for enrollment.","ALL","18 Years",{"count":93,"type":94},202,"ESTIMATED","INTERVENTIONAL",[97,98],"PHASE2","PHASE3","This study aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM). The primary goal is to compare minimal residual disease (MRD) negativity rates and overall treatment outcomes between the two groups.",[101],"Multiple Myeloma, Newly Diagnosed",[103],"consolidation","2025-03-14",{"date":106,"type":107},"2025-03-17","ACTUAL",{"date":109,"type":94},"2025-03",{"date":111,"type":94},"2029-03",{"name":5,"class":6},3]