[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510525":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":171,"collaborators":30,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":30,"eligibilityCriteria":179,"healthyVolunteers":175,"sex":180,"minAge":181,"maxAge":30,"enrollmentInfo":182,"targetDuration":30,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":30,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Safety Lead-In Cohort","EXPERIMENTAL","Participants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.",[13,14,15],"Drug: Cevostamab","Drug: Elranatamab","Drug: Tocilizumab",{"label":17,"type":10,"description":18,"interventionNames":19},"Dose Expansion Cohort (Combined Therapy)","Participants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Dose Expansion Cohort (Monotherapy)","Participants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity.",[14],[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Cevostamab","Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.",[17,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Elranatamab","Elranatamab solution for injection will be administered SC as specified in each treatment arm.",[17,21,9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Tocilizumab","Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.",[17,9],[40],{"name":41,"affiliation":42,"role":43},"Clinical Trials","Hoffmann-La Roche","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"GO43979 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":51,"role":47,"phone":30,"phoneExt":30,"email":30},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[53,67,76,86,96,100,107,116,125,134,144,153,159,165],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":30},"Royal Prince Alfred Hospital","RECRUITING","Camperdown","New South Wales","2050","Australia","AU",{"type":62,"coordinates":63},"Point",[64,65],151.17642,-33.88965,{"lat":65,"lon":64},{"facility":68,"status":55,"city":69,"state":57,"zip":70,"country":59,"countryCode":60,"cosmosGeoPoint":71,"geoPoint":75,"contacts":30},"Calvary Mater Newcastle","Waratah","2298",{"type":62,"coordinates":72},[73,74],151.72647,-32.90667,{"lat":74,"lon":73},{"facility":77,"status":55,"city":78,"state":79,"zip":80,"country":59,"countryCode":60,"cosmosGeoPoint":81,"geoPoint":85,"contacts":30},"Royal Adelaide Hospital;Haematology Clinical Trials Unit","Adelaide","South Australia","5000",{"type":62,"coordinates":82},[83,84],138.59863,-34.92866,{"lat":84,"lon":83},{"facility":87,"status":55,"city":88,"state":89,"zip":90,"country":59,"countryCode":60,"cosmosGeoPoint":91,"geoPoint":95,"contacts":30},"St. Vincent's Hospital Melbourne","Melbourne","Victoria","3065",{"type":62,"coordinates":92},[93,94],144.96332,-37.814,{"lat":94,"lon":93},{"facility":97,"status":55,"city":98,"state":89,"zip":99,"country":59,"countryCode":60,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"The Alfred Hospital","Prahan","3181",{"facility":101,"status":55,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"The Chaim Sheba Medical Center - PPDS","Ramat Gan","Central District","5262100","Israel","IL",{"facility":108,"status":55,"city":109,"state":30,"zip":110,"country":105,"countryCode":106,"cosmosGeoPoint":111,"geoPoint":115,"contacts":30},"Rambam Health Care Campus","Haifa","3109600",{"type":62,"coordinates":112},[113,114],34.99928,32.81303,{"lat":114,"lon":113},{"facility":117,"status":55,"city":118,"state":30,"zip":119,"country":105,"countryCode":106,"cosmosGeoPoint":120,"geoPoint":124,"contacts":30},"Hadassah University Hospital - Ein Kerem","Jerusalem","9112001",{"type":62,"coordinates":121},[122,123],35.21633,31.76904,{"lat":123,"lon":122},{"facility":126,"status":55,"city":127,"state":30,"zip":128,"country":105,"countryCode":106,"cosmosGeoPoint":129,"geoPoint":133,"contacts":30},"Tel Aviv Sourasky Medical Center PPDS","Tel Aviv","6423906",{"type":62,"coordinates":130},[131,132],34.78057,32.08088,{"lat":132,"lon":131},{"facility":135,"status":55,"city":136,"state":30,"zip":137,"country":138,"countryCode":30,"cosmosGeoPoint":139,"geoPoint":143,"contacts":30},"The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)","Seocho","06591","South Korea",{"type":62,"coordinates":140},[141,142],127.02,37.49056,{"lat":142,"lon":141},{"facility":145,"status":55,"city":146,"state":30,"zip":147,"country":138,"countryCode":30,"cosmosGeoPoint":148,"geoPoint":152,"contacts":30},"Seoul National University Hospital","Seoul","03080",{"type":62,"coordinates":149},[150,151],126.9784,37.566,{"lat":151,"lon":150},{"facility":154,"status":55,"city":146,"state":30,"zip":155,"country":138,"countryCode":30,"cosmosGeoPoint":156,"geoPoint":158,"contacts":30},"Severance Hospital, Yonsei University Health System","03722",{"type":62,"coordinates":157},[150,151],{"lat":151,"lon":150},{"facility":160,"status":55,"city":146,"state":30,"zip":161,"country":138,"countryCode":30,"cosmosGeoPoint":162,"geoPoint":164,"contacts":30},"Asan Medical Center.","05505",{"type":62,"coordinates":163},[150,151],{"lat":151,"lon":150},{"facility":166,"status":55,"city":146,"state":30,"zip":167,"country":138,"countryCode":30,"cosmosGeoPoint":168,"geoPoint":170,"contacts":30},"Samsung Medical Center - PPDS","06351",{"type":62,"coordinates":169},[150,151],{"lat":151,"lon":150},{"type":172,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100510525","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-activity-of-the-combination-of-cevostamab-and-elranatamab-in-participants-with-relapsed-or-refractory-multiple-myeloma-rr-mm-100510525",false,"NCT05927571","A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R\u002FR MM)","An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Diagnosis of R\u002FR MM per IMWG criteria\n* For female participants of childbearing potential: agreement to remain abstinent or use contraception\n* For male participants: agreement to remain abstinent or use a condom\n\nExclusion Criteria:\n\n* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)\n* Prior treatment with elranatamab\n* Prior allogeneic stem cell transplantation (SCT)\n* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells\n* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome\n* Participants with known history of amyloidosis\n* History of autoimmune disease\n* History of confirmed progressive multifocal leukoencephalopathy\n* Peripheral motor polyneuropathy of prespecified grade\n* Known or suspected chronic cytomegalovirus (CMV) and\u002For Epstein-Barr virus (EBV) infection\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Human immunodeficiency virus (HIV) seropositivity\n* History of central nervous system (CNS) myeloma disease\n* Significant cardiovascular disease","ALL","18 Years",{"count":183,"type":184},120,"ESTIMATED","INTERVENTIONAL",[187],"PHASE1","The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.",[190],"Relapsed or Refractory Multiple Myeloma","2026-07-01",{"date":193,"type":194},"2026-07-02","ACTUAL",{"date":196,"type":194},"2023-08-10",{"date":198,"type":184},"2027-07-31",{"name":5,"class":6},14]