[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644345":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":45,"armGroups":46,"interventions":55,"overallOfficials":81,"centralContacts":86,"locations":94,"responsibleParty":266,"collaborators":16,"id":268,"slug":16,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":269,"sex":275,"minAge":276,"maxAge":16,"enrollmentInfo":277,"targetDuration":16,"studyType":280,"phases":16,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":97,"whyStopped":16,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"≥CR rate after induction treatment","The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.","After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)",[14,18,20,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"MRD negativity rate",null,"At the end of induction phase (Week 32 \u002F approximately 8 months)",{"measure":19,"description":16,"timeFrame":17},"≥VGPR rate",{"measure":21,"description":16,"timeFrame":17},"Overall response rate",{"measure":23,"description":16,"timeFrame":24},"Duration of Response","From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.",{"measure":26,"description":16,"timeFrame":27},"Time to Response","Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months",{"measure":29,"description":16,"timeFrame":30},"Duration of Treatment","Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months",{"measure":32,"description":16,"timeFrame":33},"Progression free survival","Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months",{"measure":35,"description":16,"timeFrame":36},"Overall Survival","Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months",{"measure":38,"description":39,"timeFrame":40},"Incidence Adverse Events","Adverse events (AEs) include treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs), defined as infusion reactions (IRs) and occurrence of second primary malignancies.","From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":42,"timePerspective":43,"maskingInfo":16},"COHORT","PROSPECTIVE","This is a single-arm, multicenter, prospective observational cohort study with a planned total enrollment of 333 transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients aged ≥18 years old in China. All enrolled participants will receive the Isa-VRd induction regimen for 8 cycles (4 weeks per cycle, total 32 weeks). After induction therapy, investigators will determine whether patients continue maintenance treatment based on individual response status, followed by a 2-year long-term follow-up period from the initiation of Isa-VRd treatment, with the maximum observation window of each subject capped at 24 months.\n\nFor efficacy evaluation, minimal residual disease (MRD) testing with a cutoff of NGF=10-⁵ will be performed at multiple prespecified time points: at month 8 post-induction, and every 6 months throughout the maintenance and follow-up phase (at months 14, 20 and 26). The primary endpoint of this study is ≥CR rate after induction therapy. Secondary efficacy endpoints include stringent complete response (sCR), very good partial response (VGPR), overall response rate (ORR), duration of response (DOR), time to response (TTR), time to next treatment (TNT), progression-free survival (PFS), overall survival (OS), as well as all safety and tolerability outcomes.\n\nThroughout the entire treatment and follow-up period, all treatment-emergent adverse events (TEAEs), grade ≥3 adverse events, serious adverse events (SAEs), and adverse events of special interest (AESIs, including infusion reactions and second primary malignancies) will be continuously collected and recorded to evaluate the real-world safety profile of the Isa-VRd regimen in Chinese TI-NDMM patients. The overall planned study duration spans approximately 24 months from the first subject's enrollment to the completion of the last patient's 24-month follow-up assessment.","Adult patients (≥18 years old) with newly diagnosed multiple myeloma, ineligible for autologous stem cell transplantation due to age or comorbidities, who are scheduled to receive the Isatuximab + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd) combination regimen.",[47],{"label":48,"type":16,"description":49,"interventionNames":50},"Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen","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",[51,52,53,54],"Drug: Isatuximab","Drug: Bortezomib","Drug: Lenalidomide","Drug: Dexamethasone",[56,63,69,75],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"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.",[48],[62],"sarclisa",{"type":57,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"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",[48],[68],"Velcade, PS-341",{"type":57,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"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",[48],[74],"Revlimid",{"type":57,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"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",[48],[80],"Decadron",[82],{"name":83,"affiliation":84,"role":85},"Peng Liu","Fudan University","PRINCIPAL_INVESTIGATOR",[87,91],{"name":83,"role":88,"phone":89,"phoneExt":16,"email":90},"CONTACT","+86-021-64041990","liu.peng@zs-hospital.sh.cn",{"name":92,"role":88,"phone":16,"phoneExt":16,"email":93},"Jiadai Xu","xu.jiadai@zs-hospital.sh.cn",[95,112,125,137,151,164,177,190,203,215,227,240,253],{"facility":96,"status":97,"city":98,"state":99,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":103,"coordinates":104},"Point",[105,106],116.39723,39.9075,{"lat":106,"lon":105},[109],{"name":110,"role":88,"phone":16,"phoneExt":16,"email":111},"Junling Zhuang","zhuangjunling@pumch.cn",{"facility":113,"status":97,"city":114,"state":115,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong",{"type":103,"coordinates":117},[118,119],113.25,23.11667,{"lat":119,"lon":118},[122],{"name":123,"role":88,"phone":16,"phoneExt":16,"email":124},"Zhongjun Xia","xiazhj@sysucc.org.cn",{"facility":126,"status":97,"city":127,"state":115,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Shenzhen People's Hospital","Shenzhen",{"type":103,"coordinates":129},[130,131],114.0683,22.54554,{"lat":131,"lon":130},[134],{"name":135,"role":88,"phone":16,"phoneExt":16,"email":136},"Jihao Zhou","zhoujihao@aliyun.com",{"facility":138,"status":97,"city":139,"state":140,"zip":141,"country":100,"countryCode":101,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The First Affiliated Hospital of Guangxi Medical University","Naning","Guangxi","450000",{"type":103,"coordinates":143},[144,145],106.334,24.0658,{"lat":145,"lon":144},[148],{"name":149,"role":88,"phone":16,"phoneExt":16,"email":150},"Jun Luo","luojungz@medmail.com.cn",{"facility":152,"status":97,"city":153,"state":154,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Harbin Institute of Hematologic Oncology","Harbin","Heilongjiang",{"type":103,"coordinates":156},[157,158],126.65,45.75,{"lat":158,"lon":157},[161],{"name":162,"role":88,"phone":16,"phoneExt":16,"email":163},"Tiejun Gong","gongtiejun678@163.com",{"facility":165,"status":97,"city":166,"state":167,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Henan Cancer Hospital","Zhengzhou","Henan",{"type":103,"coordinates":169},[170,171],113.64861,34.75778,{"lat":171,"lon":170},[174],{"name":175,"role":88,"phone":16,"phoneExt":16,"email":176},"Baijun Fang","zlyyfangbaijun1051@zzu.edu.cn",{"facility":178,"status":97,"city":179,"state":180,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.","Wuhan","Hubei",{"type":103,"coordinates":182},[183,184],114.26667,30.58333,{"lat":184,"lon":183},[187],{"name":188,"role":88,"phone":16,"phoneExt":16,"email":189},"Chunrui Li","cunrui5650@hust.edu.cn",{"facility":191,"status":97,"city":192,"state":193,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Jiangsu Provincial People's Hospital","Nanjing","Jiangsu",{"type":103,"coordinates":195},[196,197],118.77778,32.06167,{"lat":197,"lon":196},[200],{"name":201,"role":88,"phone":16,"phoneExt":16,"email":202},"Xiaoyan Qu","quxiaoyan@jsph.org.cn",{"facility":204,"status":97,"city":205,"state":193,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Affiliated Hospital of Nantong University","Nantong",{"type":103,"coordinates":207},[208,209],120.87472,32.03028,{"lat":209,"lon":208},[212],{"name":213,"role":88,"phone":16,"phoneExt":16,"email":214},"Hongming Huang","hhmmmc@163.com",{"facility":216,"status":97,"city":217,"state":218,"zip":219,"country":100,"countryCode":101,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Fudan University Affiliated Zhongshan Hospital","Shanghai","Shanghai Municipality","200032",{"type":103,"coordinates":221},[222,223],121.45806,31.22222,{"lat":223,"lon":222},[226],{"name":83,"role":88,"phone":89,"phoneExt":16,"email":90},{"facility":228,"status":97,"city":229,"state":230,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Xijing Hospital, Air Force Medical University","Xi’an","Shanxi",{"type":103,"coordinates":232},[233,234],113.52486,35.99785,{"lat":234,"lon":233},[237],{"name":238,"role":88,"phone":16,"phoneExt":16,"email":239},"Guangxun Gao","gaoguangxun@fmmu.edu.cn",{"facility":241,"status":97,"city":242,"state":243,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Sichuan Provincial People's Hospital","Chengdu","Sichuan",{"type":103,"coordinates":245},[246,247],104.06667,30.66667,{"lat":247,"lon":246},[250],{"name":251,"role":88,"phone":16,"phoneExt":16,"email":252},"Xiaobing Huang","huangxiaobing@med.uestc.edu.cn",{"facility":254,"status":97,"city":255,"state":256,"zip":16,"country":100,"countryCode":101,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"The First Affiliated Hospital of Kunming Medical University","Kunming","Yunnan",{"type":103,"coordinates":258},[259,260],102.71833,25.03889,{"lat":260,"lon":259},[263],{"name":264,"role":88,"phone":16,"phoneExt":16,"email":265},"Mingxia Shi","shmxia2002@sina.com",{"type":85,"investigatorFullName":83,"investigatorTitle":267,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Chief of Hematology department","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":278,"type":279},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.",[283],"Multiple Myeloma",[285,286,287,283],"isatuximab","transplant-ineligible newly diagnosed multiple myeloma","TI NDMM","2026-06-17",{"date":290,"type":291},"2026-06-23","ACTUAL",{"date":293,"type":279},"2026-06",{"date":295,"type":279},"2030-09",{"name":5,"class":6},13]