[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644345":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":43,"centralContacts":48,"locations":56,"responsibleParty":228,"collaborators":10,"id":230,"slug":231,"hasResults":232,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":232,"sex":238,"minAge":239,"maxAge":10,"enrollmentInfo":240,"targetDuration":10,"studyType":243,"phases":10,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen",null,"Arm Description:\n\nIsatuximab 10 mg\u002Fkg Intravenous injection\n\n* Cycle 1: Every weeks on Days 1, 8, 15, and 22\n* Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg\u002Fm²\n* Cycles 1-8: Days 1, 8, and 15 of each cycle Lenalidomide oral 25 mg\u002Fday\n* Cycles 1-8: Days 1-21 at 25 mg\u002Fday (10 mg\u002Fday for patients with creatinine clearance \\[CrCl\\] ≥30 and \\\u003C60 mL\u002Fmin) Dexamethasone oral 20 mg\n* Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen",[13,14,15,16],"Drug: Isatuximab","Drug: Bortezomib","Drug: Lenalidomide","Drug: Dexamethasone",[18,25,31,37],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Isatuximab","Isatuximab 10 mg\u002Fkg Intravenous (IV) infusion\n\n* Cycle 1: Every weeks on Days 1, 8, 15, and 22\n* Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally.",[9],[24],"sarclisa",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Bortezomib","Bortezomib subcutaneous injection 1.3 mg\u002Fm²\n\n• Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen",[9],[30],"Velcade, PS-341",{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Lenalidomide","Lenalidomide oral 25 mg\u002Fday\n\n• Cycles 1-8: Days 1-21 at 25 mg\u002Fday (10 mg\u002Fday for patients with creatinine clearance \\[CrCl\\] ≥30 and \\\u003C60 mL\u002Fmin) Following Cycle 8, the investigator may assess and adjust the treatment regimen",[9],[36],"Revlimid",{"type":19,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Dexamethasone","Dexamethasone oral 20 mg\n\n• Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen",[9],[42],"Decadron",[44],{"name":45,"affiliation":46,"role":47},"Peng Liu","Fudan University","PRINCIPAL_INVESTIGATOR",[49,53],{"name":45,"role":50,"phone":51,"phoneExt":10,"email":52},"CONTACT","+86-021-64041990","liu.peng@zs-hospital.sh.cn",{"name":54,"role":50,"phone":10,"phoneExt":10,"email":55},"Jiadai Xu","xu.jiadai@zs-hospital.sh.cn",[57,74,87,99,113,126,139,152,165,177,189,202,215],{"facility":58,"status":59,"city":60,"state":61,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":65,"coordinates":66},"Point",[67,68],116.39723,39.9075,{"lat":68,"lon":67},[71],{"name":72,"role":50,"phone":10,"phoneExt":10,"email":73},"Junling Zhuang","zhuangjunling@pumch.cn",{"facility":75,"status":59,"city":76,"state":77,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong",{"type":65,"coordinates":79},[80,81],113.25,23.11667,{"lat":81,"lon":80},[84],{"name":85,"role":50,"phone":10,"phoneExt":10,"email":86},"Zhongjun Xia","xiazhj@sysucc.org.cn",{"facility":88,"status":59,"city":89,"state":77,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Shenzhen People's Hospital","Shenzhen",{"type":65,"coordinates":91},[92,93],114.0683,22.54554,{"lat":93,"lon":92},[96],{"name":97,"role":50,"phone":10,"phoneExt":10,"email":98},"Jihao Zhou","zhoujihao@aliyun.com",{"facility":100,"status":59,"city":101,"state":102,"zip":103,"country":62,"countryCode":63,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"The First Affiliated Hospital of Guangxi Medical University","Naning","Guangxi","450000",{"type":65,"coordinates":105},[106,107],106.334,24.0658,{"lat":107,"lon":106},[110],{"name":111,"role":50,"phone":10,"phoneExt":10,"email":112},"Jun Luo","luojungz@medmail.com.cn",{"facility":114,"status":59,"city":115,"state":116,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Harbin Institute of Hematologic Oncology","Harbin","Heilongjiang",{"type":65,"coordinates":118},[119,120],126.65,45.75,{"lat":120,"lon":119},[123],{"name":124,"role":50,"phone":10,"phoneExt":10,"email":125},"Tiejun Gong","gongtiejun678@163.com",{"facility":127,"status":59,"city":128,"state":129,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":65,"coordinates":131},[132,133],113.64861,34.75778,{"lat":133,"lon":132},[136],{"name":137,"role":50,"phone":10,"phoneExt":10,"email":138},"Baijun Fang","zlyyfangbaijun1051@zzu.edu.cn",{"facility":140,"status":59,"city":141,"state":142,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.","Wuhan","Hubei",{"type":65,"coordinates":144},[145,146],114.26667,30.58333,{"lat":146,"lon":145},[149],{"name":150,"role":50,"phone":10,"phoneExt":10,"email":151},"Chunrui Li","cunrui5650@hust.edu.cn",{"facility":153,"status":59,"city":154,"state":155,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Jiangsu Provincial People's Hospital","Nanjing","Jiangsu",{"type":65,"coordinates":157},[158,159],118.77778,32.06167,{"lat":159,"lon":158},[162],{"name":163,"role":50,"phone":10,"phoneExt":10,"email":164},"Xiaoyan Qu","quxiaoyan@jsph.org.cn",{"facility":166,"status":59,"city":167,"state":155,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Affiliated Hospital of Nantong University","Nantong",{"type":65,"coordinates":169},[170,171],120.87472,32.03028,{"lat":171,"lon":170},[174],{"name":175,"role":50,"phone":10,"phoneExt":10,"email":176},"Hongming Huang","hhmmmc@163.com",{"facility":178,"status":59,"city":179,"state":180,"zip":181,"country":62,"countryCode":63,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Fudan University Affiliated Zhongshan Hospital","Shanghai","Shanghai Municipality","200032",{"type":65,"coordinates":183},[184,185],121.45806,31.22222,{"lat":185,"lon":184},[188],{"name":45,"role":50,"phone":51,"phoneExt":10,"email":52},{"facility":190,"status":59,"city":191,"state":192,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Xijing Hospital, Air Force Medical University","Xi’an","Shanxi",{"type":65,"coordinates":194},[195,196],113.52486,35.99785,{"lat":196,"lon":195},[199],{"name":200,"role":50,"phone":10,"phoneExt":10,"email":201},"Guangxun Gao","gaoguangxun@fmmu.edu.cn",{"facility":203,"status":59,"city":204,"state":205,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Sichuan Provincial People's Hospital","Chengdu","Sichuan",{"type":65,"coordinates":207},[208,209],104.06667,30.66667,{"lat":209,"lon":208},[212],{"name":213,"role":50,"phone":10,"phoneExt":10,"email":214},"Xiaobing Huang","huangxiaobing@med.uestc.edu.cn",{"facility":216,"status":59,"city":217,"state":218,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"The First Affiliated Hospital of Kunming Medical University","Kunming","Yunnan",{"type":65,"coordinates":220},[221,222],102.71833,25.03889,{"lat":222,"lon":221},[225],{"name":226,"role":50,"phone":10,"phoneExt":10,"email":227},"Mingxia Shi","shmxia2002@sina.com",{"type":47,"investigatorFullName":45,"investigatorTitle":229,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Chief of Hematology department","100644345","isatuximab-vrd-in-transplant-ineligible-newly-diagnosed-multiple-myeloma-patients-100644345",false,"NCT07663253","Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients","A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients","CHAMPION-01","Inclusion Criteria:\n\n* Age ≥18 years\n* Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines\n* Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):\n\n  * Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL\n  * Platelet count ≥50×10⁹\u002FL\n  * Calculated creatinine clearance ≥30 mL\u002Fmin (using Cockcroft-Gault formula)\n  * Total bilirubin ≤3× upper limit of normal (ULN)\n* TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)\n\nExclusion Criteria:\n\n* Patients currently participating in other interventional clinical studies\n* Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients\n* Severe bacteremia at the time of administration\n* Currently uncontrolled cardiovascular disease, including:\n\n  * Uncontrolled hypertension\n  * Uncontrolled arrhythmia\n  * Uncontrollable congestive heart failure\n  * Unstable angina\n* Patients with peripheral neuropathy ≥Grade 2\n* Active infectious disease, known human immunodeficiency virus (HIV) positivity, active hepatitis B or hepatitis C\n* Patients who are currently pregnant\n* Patients who, at the physician's discretion, are unable to tolerate any drug in the combination regimen","ALL","18 Years",{"count":241,"type":242},333,"ESTIMATED","OBSERVATIONAL","Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China.\n\nAnd Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients\n\nParticipants will:\n\nReceive Isatuximab 10 mg\u002Fkg iv\n\n* Cycle 1: Every weeks on Days 1, 8, 15, and 22\n* Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg\u002Fm²\n* Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg\u002Fday\n* Cycles 1-8: Days 1-21 at 25 mg\u002Fday (10 mg\u002Fday for patients with creatinine clearance \\[CrCl\\] ≥30 and \\\u003C60 mL\u002Fmin) Receive Dexamethasone oral 20 mg\n* Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.\n\nDuring the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.\n\nDuring the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.",[246],"Multiple Myeloma",[248,249,250,246],"isatuximab","transplant-ineligible newly diagnosed multiple myeloma","TI NDMM","2026-06-17",{"date":253,"type":254},"2026-06-23","ACTUAL",{"date":256,"type":242},"2026-06",{"date":258,"type":242},"2030-09",{"name":5,"class":6},13]