[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653770":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":39,"overallOfficials":11,"centralContacts":45,"locations":11,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":11},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Minimal residual disease (MRD) negativity rate",null,"9 months",[14,17,19,21,23,25],{"measure":15,"description":11,"timeFrame":16},"Adverse events and serious adverse events","Up to 2 year",{"measure":18,"description":11,"timeFrame":16},"Sustained MRD negativity rate",{"measure":20,"description":11,"timeFrame":16},"Overall response rate (ORR)",{"measure":22,"description":11,"timeFrame":16},"Complete response rate (CR)",{"measure":24,"description":11,"timeFrame":16},"Progression-free survival (PFS)",{"measure":26,"description":11,"timeFrame":16},"Duration of response (DoR)",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE",[34],{"label":35,"type":36,"description":11,"interventionNames":37},"BsAbs-treatment group","EXPERIMENTAL",[38],"Drug: anti-BCMA\u002FCD3 bispecific antibody",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"DRUG","anti-BCMA\u002FCD3 bispecific antibody","Anti-BCMA\u002FCD3 bispecific antibody (Elranatamab) will be administered via a subcutaneous injection (SC).",[35],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Gang An","CONTACT","86-022-23909171","angang@ihcams.ac.cn",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100653770","phase-2-safety-and-efficacy-of-elranatamab-plus-isatuximab-bortezomib-and-lenalidomide-in-ultra-high-risk-multiple-myeloma-100653770",false,"NCT07789522","Safety and Efficacy of Elranatamab Plus Isatuximab, Bortezomib, and Lenalidomide in Ultra-High-Risk Multiple Myeloma","A Clinical Study Evaluating the Safety and Efficacy of Elranatamab in Combination With Isatuximab, Bortezomib, and Lenalidomide in Patients With Ultra-High-Risk Multiple Myeloma.","HRMM-001","Inclusion Criteria:\n\n1. The subject voluntarily signs the informed consent form (ICF).\n2. Aged 18-70 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n\nNewly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria:\n\n1. Serum M-protein ≥1.0 g\u002FdL\n2. Urine M-protein ≥200 mg\u002F24 hours\n3. Serum involved free light chain ≥10 mg\u002FdL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria:\n\n（1）del(17p) with a clonal fraction \\>20% and\u002For a TP53 mutation （2）An IGH translocation \\[t(4;14), t(14;16), or t(14;20)\\] combined with 1q+ or del(1p32) （3）del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion （5）β2-microglobulin ≥5.5 mg\u002FL with a normal serum creatinine level\n\nExclusion Criteria:\n\n1. Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis.\n2. Peripheral neuropathy of Grade \\>1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg\u002Fday for 4 days, provided that the course is completed within 14 days before randomization.\n3. Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients.\n4. Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment.\n5. Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.","ALL","18 Years","70 Years",{"count":65,"type":66},15,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is a prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma.",[72],"Multiple Myeloma (MM)",[74,75],"BCMA\u002FCD3 bispecific antibody","Elranatamab","NOT_YET_RECRUITING","2026-08-24",{"date":79,"type":80},"2026-08-27","ACTUAL",{"date":82,"type":66},"2026-10-01",{"date":84,"type":66},"2028-10-30",{"name":5,"class":6}]