[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639133":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":37,"locations":46,"responsibleParty":60,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":30,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":30,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Universitätsklinikum Hamburg-Eppendorf","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose level 1 (Phase I)","EXPERIMENTAL","First dose level of etentamig to be explored in combination with Isa-VRd",[13,14,15],"Drug: Etentamig","Drug: Isatuximab","Drug: Bortezomib + Lenalidomide + Dexamethasone",{"label":17,"type":10,"description":18,"interventionNames":19},"Dose Level 2 (Phase I)","Second dose level of etentamig to be explored in combination with Isa-VRd",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"RP2D in Phase II","RP2D of etentamig to be explored in combination with Isa-VRd",[13,14,15],[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Etentamig","Administered per the protocol",[17,9,21],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Isatuximab",[17,9,21],{"type":26,"name":35,"description":28,"armGroupLabels":36,"otherNames":30},"Bortezomib + Lenalidomide + Dexamethasone",[17,9,21],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Katja Weisel","CONTACT","+4940-7410-0","k.weisel@uke.de",{"name":44,"role":40,"phone":41,"phoneExt":30,"email":45},"Lisa Leypoldt","l.leypoldt@uke.de",[47],{"facility":48,"status":30,"city":49,"state":30,"zip":30,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Medical Center Hamburg-Eppendorf","Hamburg","Germany","DE",{"type":53,"coordinates":54},"Point",[55,56],9.99302,53.55073,{"lat":56,"lon":55},[59],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[63,66],{"name":64,"class":65},"AbbVie","INDUSTRY",{"name":67,"class":65},"Sanofi","100639133","phase-1-etenta-isa-vrd-in-newly-diagnosed-high-risk-multiple-myeloma-100639133",false,"NCT07600151","Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma","A Clinical Phase I\u002FII, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients","CONQUISTADOR","Inclusion Criteria:\n\n* Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.\n* Participants must have High-risk myeloma according to IMS\u002FIMWG CGS\n* Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.\n* Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).\n* Participants must have clinical laboratory values within a prespecified range.\n\nExclusion Criteria:\n\n* Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.\n* known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia\n* Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol\n* known central nervous system involvement by MM.","ALL","18 Years",{"count":79,"type":80},220,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE1","PHASE2","This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.",[87,88],"Myeloma Multiple","Myeloma","NOT_YET_RECRUITING","2026-05-14",{"date":92,"type":93},"2026-05-20","ACTUAL",{"date":95,"type":80},"2026-12-01",{"date":97,"type":80},"2036-12-31",{"name":5,"class":6},1]