[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530914":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":134,"collaborators":26,"id":138,"slug":26,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":26,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":26,"maxAge":26,"enrollmentInfo":145,"targetDuration":26,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Rapid Response Group","Daratumumab, bortezomib, dexamethasone",[12,13,14],"Drug: Daratumumab","Drug: Bortezomib","Drug: Dexamethasone",{"label":16,"type":6,"description":17,"interventionNames":18},"Non-Rapid Response Group","Daratumumab, venetoclax, dexamethasone",[12,14,19],"Drug: Venetoclax",[21,27,31,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Daratumumab","Daratumumab 16 mg\u002Fkg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.\n\nDaratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Bortezomib","All patients received 1.0-1.3 mg\u002Fm2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Dexamethasone","All patients received 20-40 mg oral or intravenous dexamethasone",[16,9],{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"Venetoclax","All patients received venetoclax 400mg daily.",[16],[40],{"name":41,"affiliation":5,"role":42},"Jin Lu","PRINCIPAL_INVESTIGATOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":26,"email":47},"CONTACT","+8613311491805","jin1lu@sina.com",[49,67,78,89,104,119],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Beijing","Beijing Municipality","100044","China",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62,66],{"name":63,"role":45,"phone":64,"phoneExt":26,"email":65},"Yang Liu","+8613716926210","pkuphliuyang@bjmu.edu.cn",{"name":41,"role":42,"phone":26,"phoneExt":26,"email":26},{"facility":68,"status":50,"city":51,"state":52,"zip":69,"country":54,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Capital Medical University Affiliated Fuxing Hospital","100045",{"type":56,"coordinates":71},[58,59],{"lat":59,"lon":58},[74],{"name":75,"role":45,"phone":76,"phoneExt":26,"email":77},"Liru Wang, M.D.","86-18618238652","wanglirumail@126.com",{"facility":79,"status":50,"city":51,"state":52,"zip":80,"country":54,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"Beijing Anzhen Hospital","101118",{"type":56,"coordinates":82},[58,59],{"lat":59,"lon":58},[85],{"name":86,"role":45,"phone":87,"phoneExt":26,"email":88},"Yini Wang, M.D.","86-139 0108 6559","catenny@hotmail.com",{"facility":90,"status":50,"city":91,"state":92,"zip":93,"country":54,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Chinese PLA Eastern Theater General Hospital","Nanjing","Jiangsu","210000",{"type":56,"coordinates":95},[96,97],118.77778,32.06167,{"lat":97,"lon":96},[100],{"name":101,"role":45,"phone":102,"phoneExt":26,"email":103},"Xianghua Huang, M.D.","86-13770648824","13770648824@163.com",{"facility":105,"status":50,"city":106,"state":107,"zip":108,"country":54,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Qingdao Municipal Hospital","Qingdao","Shandong","266011",{"type":56,"coordinates":110},[111,112],120.38042,36.06488,{"lat":112,"lon":111},[115],{"name":116,"role":45,"phone":117,"phoneExt":26,"email":118},"Yuping Zhong","86-13501098223","zhongyp3352@126.com",{"facility":120,"status":50,"city":121,"state":122,"zip":123,"country":54,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"The First Affiliated Hospital of Xi'an Jiao Tong University","Xi’an","Shanxi","710061",{"type":56,"coordinates":125},[126,127],113.52486,35.99785,{"lat":127,"lon":126},[130],{"name":131,"role":45,"phone":132,"phoneExt":26,"email":133},"Huasheng Liu, M.D.","86-18991232963","Lhs681995@126.com",{"type":135,"investigatorFullName":136,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Jin Lu, MD","Principal Investigator","100530914",false,"NCT06192979","Optimize First-line Treatment for AL Amyloidosis With t (11; 14)","Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)","Inclusion Criteria:\n\n1. Diagnosis of systemic AL amyloidosis;\n2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;\n3. Life expectancy greater than 12 weeks;\n4. HGB ≥70g\u002FL;\n5. Blood oxygen saturation \\>90%;\n6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;\n7. Informed consent explained to, understood by and signed by the patient.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","ALL",{"count":146,"type":147},41,"ESTIMATED","INTERVENTIONAL",[150],"NA","Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.",[153,154],"Amyloidosis; Systemic","AL Amyloidosis",[156,157,158],"t(11;14)","Rapid Response","AL amyloidosis","2026-03-06",{"date":161,"type":162},"2026-03-09","ACTUAL",{"date":164,"type":162},"2024-01-05",{"date":166,"type":147},"2027-03-31",{"name":136,"class":6},6]