[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649267":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":20,"responsibleParty":30,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":20,"enrollmentInfo":40,"targetDuration":20,"studyType":43,"phases":44,"briefSummary":47,"conditions":48,"keywords":20,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":20},{"fullName":5,"class":6},"The Affiliated People's Hospital of Ningbo University","OTHER_GOV",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Isa-VRdlite for high risk fail MM patinets base on CPSc","EXPERIMENTAL",[12,13],"Drug: Isatuximab","Drug: VRD",[15,21],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Isatuximab","Newly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below:\n\nIsatuximab (Isa) 10 mg\u002Fkg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy.\n\nReduced-intensity VRD (VRDlite) Bortezomib (V): 1.0 mg\u002Fm² subcutaneously on Days 1, 8, 15 and 22 of each cycle. Lenalidomide (R): 10 mg orally once daily on Days 1-21 of each cycle; individualized dose reduction shall be performed for patients with renal impairment according to estimated glomerular filtration rate (eGFR).",[9],null,{"type":16,"name":22,"description":18,"armGroupLabels":23,"otherNames":20},"VRD",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":20,"email":29},"Yuxiao Wang","CONTACT","+8613486889847","799161574@qq.com",{"type":31,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100649267","phase-2-isa-vrdlite-for-of-frail-andor-much-older-patients-with-high-risk-newly-diagnosed-multiple-myeloma-base-on-circulating-plasma-cells-100649267",false,"NCT07732712","Isa-VRdlite for of Frail and\u002For Much Older Patients With High Risk Newly Diagnosed Multiple Myeloma Base on Circulating Plasma Cells","Inclusion Criteria:\n\n* Aged ≥ 18 years with newly diagnosed symptomatic multiple myeloma who have not received any prior anti-myeloma therapy.\n* Confirmed positive circulating abnormal plasma cells (CPCs) in peripheral blood via flow cytometry (CPCs ≥ 0.07%).\n* Deemed ineligible for autologous hematopoietic stem cell transplantation due to advanced age, poor physical performance, or underlying comorbidities precluding transplant tolerance.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.\n* Estimated life expectancy of at least 6 months.\n* Adequate baseline function of major vital organs to tolerate treatment; no absolute contraindications on complete blood count, liver and renal function, cardiac enzymes or coagulation profile.\n* Voluntarily participate in this study, provide written informed consent, and be available for regular follow-up visits.\n\nExclusion Criteria:\n\n* Diagnosis of primary plasma cell leukemia, solitary plasmacytoma, smoldering multiple myeloma or secondary multiple myeloma.\n\n  * Prior exposure to any anti-myeloma agents, radiotherapy, or stem cell transplantation.\n  * Concurrent other malignant tumors (except for in situ carcinoma cured for more than 5 years).\n  * Severe active infection, active autoimmune disease, or severe cardiovascular and cerebrovascular diseases (NYHA class III-IV heart failure, recent myocardial infarction or cerebral infarction).\n  * Known hypersensitivity to isatuximab, bortezomib, lenalidomide, dexamethasone, or any excipients of the study drugs.\n  * Pregnant or breastfeeding females.\n  * Unwilling or unable to complete follow-up, or patients with incomplete clinical data.","ALL","18 Years",{"count":41,"type":42},15,"ESTIMATED","INTERVENTIONAL",[45,46],"PHASE2","PHASE3","To evaluate the overall response rate, safety, and the 12-cycle clearance rate of circulating plasma cells (CPCs) in patients with newly diagnosed transplant-ineligible multiple myeloma stratified as high-risk based on circulating plasma cell assessment treated with isatuximab combined with reduced-dose VRD regimen",[49],"Multiple Myeloma","NOT_YET_RECRUITING","2026-07-26",{"date":53,"type":54},"2026-07-29","ACTUAL",{"date":56,"type":42},"2026-08-01",{"date":58,"type":42},"2028-12-01",{"name":5,"class":6}]