[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526916":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":90,"centralContacts":91,"locations":101,"responsibleParty":122,"collaborators":90,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":90,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":90,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":104,"whyStopped":90,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Treatment","EXPERIMENTAL","Pretrial induction chemotherapy (if required): bortezomib, cyclophosphamid, dexamethasone (VCD).\n\nInduction Chemotherapy: Daratumumab, Carfilzomib,Lenalidomide, Dexamethasone, CisPlatin, epirubicin, Cyclophosphamide and Etoposide (Dara-KRd-PACE).\n\nAutologous Stem Cell Transplant (ASCT) : Melphalan, ASCT.\n\nConsolidation: Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone (Dara-KRd).\n\nMaintenance: Daratumumab, Carfilzomib, and Dexamethasone (Dara-Kd).",[13,14,15,16,17,18,19,20,21,22,23],"Drug: Daratumumab","Drug: Carfilzomib","Drug: Lenalidomide","Drug: Dexamethasone","Drug: Cisplatin","Drug: epirubicin","Drug: Cyclophosphamide","Drug: Etoposide","Drug: Melphalan","Procedure: ASCT","Drug: bortezomib",[25,32,38,44,50,56,61,66,71,77,84],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Daratumumab","Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.",[9],[31],"Darzalex",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Carfilzomib","Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.",[9],[37],"Kyprolis",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Lenalidomide","Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.",[9],[43],"Revlimid",{"type":26,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Dexamethasone","Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance",[9],[49],"Baycadron",{"type":26,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Cisplatin","Given by vein: days 1-4 of each Induction cycle",[9],[55],"Platinol",{"type":26,"name":57,"description":52,"armGroupLabels":58,"otherNames":59},"epirubicin",[9],[60],"Pharmorubicin",{"type":26,"name":62,"description":52,"armGroupLabels":63,"otherNames":64},"Cyclophosphamide",[9],[65],"Cytoxan",{"type":26,"name":67,"description":52,"armGroupLabels":68,"otherNames":69},"Etoposide",[9],[70],"Eposin",{"type":26,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Melphalan","Given by vein: day -1 of Transplant",[9],[76],"Alkeran",{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"PROCEDURE","ASCT","day 0 of Transplant",[9],[83],"autologous stem cell transplantation",{"type":26,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"bortezomib","given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy",[9],[89],"Velcade",null,[92,97],{"name":93,"role":94,"phone":95,"phoneExt":90,"email":96},"Chunyan Sun, MD","CONTACT","+8602785726387","suncy0618@163.com",{"name":98,"role":94,"phone":99,"phoneExt":90,"email":100},"Jian Xu, MD","+8602785726006","xujian01222@163.com",[102],{"facility":103,"status":104,"city":105,"state":106,"zip":90,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","China","CN",{"type":110,"coordinates":111},"Point",[112,113],114.26667,30.58333,{"lat":113,"lon":112},[116,117,118,120],{"name":93,"role":94,"phone":95,"phoneExt":90,"email":96},{"name":98,"role":94,"phone":99,"phoneExt":90,"email":100},{"name":93,"role":119,"phone":90,"phoneExt":90,"email":90},"PRINCIPAL_INVESTIGATOR",{"name":98,"role":121,"phone":90,"phoneExt":90,"email":90},"SUB_INVESTIGATOR",{"type":119,"investigatorFullName":123,"investigatorTitle":124,"investigatorAffiliation":5,"oldNameTitle":90,"oldOrganization":90},"Chunyan Sun","Professor","100526916","phase-2-study-to-evaluate-the-safety-and-efficacy-of-daratumumab-and-carfilzomib-based-inductionconsolidationmaintenance-therapy-in-transplant-eligible-ultra-high-risk-newly-diagnosed-multiple-myeloma-100526916",false,"NCT06140966","Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma","Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)\"Double hit\"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia.\n2. Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.\n3. Aged 18 years to 70 years.\n4. Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).\n5. Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.\n\nExclusion Criteria:\n\n1. No evidence of high-risk disease.\n2. Primary diagnosis of Waldenstrom's disease\u002FPOEMS syndrome\u002Flight chain amyloidosis.\n3. Received therapy for multiple myeloma.\n4. Prior or concurrent invasive malignancies.\n5. Eastern Cooperative Oncology Group (ECOG) score \\>2 before induction chemotherapy.\n6. Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin, cyclophosphamide,melphalan, and etoposide.\n7. Participants with contraindication to thromboprophylaxis.\n8. Any uncontrolled or severe cardiovascular or pulmonary disease.\n9. Platelet count \\\u003C 50,000\u002FμL, absolute neutrophil count \\\u003C1000\u002FμL, and haemoglobin \\\u003C60 g\u002FL before induction chemotherapy.\n10. Calculated creatinine clearance \\\u003C30 mL\u002Fmin, alanine transaminase (ALT) or aspertate aminotransferase (AST) \\>3 times upper limit of normal (ULN). Bilirubin \\>2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin \\>2.0 times ULN).\n11. Known to be seropositive for history of HIV or known to have active hepatitis B or hepatitis C.\n12. Ejection fraction by echocardiogram (ECHO) ≥ 45%, pulmonary function studies \\\u003C50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) \\\u003C 50% of predicted.\n13. Uncontrolled or severe cardiovascular or pulmonary disease, clinically significant cardiac disease, uncontrolled diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n14. Known\u002Funderlying medical conditions that, in the investigator's opinion, would make the administration of the study drug hazardous.\n15. Participant is a woman who is pregnant, or breast feeding, or planning to become pregnant while enrolled in this trial or within at least 6 months after the last dose of trial treatment. Or, participant is a man who plans to father a child while taking part in this trial or within at least 6 months after the last dose of trial treatment.\n16. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an interventional investigational study.\n17. Major surgery within 2 weeks before treatment protocol registration or has not fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.\n18. Known or suspected of not being able to comply with the study protocol.","ALL","18 Years","70 Years",{"count":136,"type":137},54,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","This study will assess whether the combination of daratumumab and carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma",[143,144,145],"Multiple Myeloma","Primary Plasma Cell Leukemia","Extramedullary Multiple Myeloma",[27,33,143,147,144,145,148,149],"Ultra High-risk","Autologous stem cell transplant","Double hit","2025-04-12",{"date":152,"type":153},"2025-04-16","ACTUAL",{"date":155,"type":153},"2023-10-20",{"date":157,"type":137},"2027-10-20",{"name":5,"class":6},1]