[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566016":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":32,"responsibleParty":151,"collaborators":153,"id":157,"slug":30,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":30,"eligibilityCriteria":161,"healthyVolunteers":158,"sex":162,"minAge":163,"maxAge":30,"enrollmentInfo":164,"targetDuration":30,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"European Myeloma Network B.V.","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Teclistamab","EXPERIMENTAL","Teclistamab will be administered via a subcutaneous injection (SC)",[13],"Drug: Teclistamab",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],[19],"JNJ-64007957",[21],{"name":22,"affiliation":23,"role":24},"Murielle Roussel, MD","CHU Limoges","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Chiara Del Pietro","CONTACT","+31 102687065",null,"chiara.delpietro@emn.org",[33,47,58,69,81,93,104,115,127,139],{"facility":34,"status":35,"city":36,"state":30,"zip":30,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"South Australia Health","RECRUITING","Adelaide","Australia",{"type":39,"coordinates":40},"Point",[41,42],138.59863,-34.92866,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":30,"phoneExt":30,"email":30},"Horvath",{"facility":48,"status":35,"city":49,"state":30,"zip":30,"country":37,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Westmead Hospital","Sydney",{"type":39,"coordinates":51},[52,53],151.20732,-33.86785,{"lat":53,"lon":52},[56],{"name":57,"role":28,"phone":30,"phoneExt":30,"email":30},"Kwok",{"facility":23,"status":35,"city":59,"state":30,"zip":30,"country":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Limoges","France",{"type":39,"coordinates":62},[63,64],1.24759,45.83362,{"lat":64,"lon":63},[67],{"name":68,"role":28,"phone":30,"phoneExt":30,"email":30},"Roussel",{"facility":70,"status":71,"city":72,"state":30,"zip":30,"country":60,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Paris St Louis","NOT_YET_RECRUITING","Paris",{"type":39,"coordinates":74},[75,76],2.3488,48.85341,{"lat":76,"lon":75},[79],{"name":80,"role":28,"phone":30,"phoneExt":30,"email":30},"Arnulf",{"facility":82,"status":35,"city":83,"state":30,"zip":30,"country":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"University Hospital Essen","Essen","Germany",{"type":39,"coordinates":86},[87,88],7.01228,51.45657,{"lat":88,"lon":87},[91],{"name":92,"role":28,"phone":30,"phoneExt":30,"email":30},"Carpinteiro",{"facility":94,"status":35,"city":95,"state":30,"zip":30,"country":84,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University Hospital Heidelberg","Heidelberg",{"type":39,"coordinates":97},[98,99],8.69079,49.40768,{"lat":99,"lon":98},[102],{"name":103,"role":28,"phone":30,"phoneExt":30,"email":30},"Schönland",{"facility":105,"status":35,"city":106,"state":30,"zip":30,"country":84,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University Hospital Würzburg","Würzburg",{"type":39,"coordinates":108},[109,110],9.95121,49.79391,{"lat":110,"lon":109},[113],{"name":114,"role":28,"phone":30,"phoneExt":30,"email":30},"Kortüm",{"facility":116,"status":35,"city":117,"state":30,"zip":30,"country":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"General Hospital of Athens \"Alexandra\"","Athens","Greece",{"type":39,"coordinates":120},[121,122],23.72784,37.98376,{"lat":122,"lon":121},[125],{"name":126,"role":28,"phone":30,"phoneExt":30,"email":30},"Kastritis",{"facility":128,"status":35,"city":129,"state":30,"zip":30,"country":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Fondazione I.R.C.C.S Policlinico \"San Matteo\"","Pavia","Italy",{"type":39,"coordinates":132},[133,134],9.15917,45.19205,{"lat":134,"lon":133},[137],{"name":138,"role":28,"phone":30,"phoneExt":30,"email":30},"Palladini",{"facility":140,"status":35,"city":141,"state":30,"zip":30,"country":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"UMC Utrecht","Utrecht","Netherlands",{"type":39,"coordinates":144},[145,146],5.12222,52.09083,{"lat":146,"lon":145},[149],{"name":150,"role":28,"phone":30,"phoneExt":30,"email":30},"Minnema",{"type":152,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[154],{"name":155,"class":156},"Janssen Research & Development","UNKNOWN","100566016",false,"NCT06649695","A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis","Inclusion Criteria:\n\n* Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry\u002F immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.\n* Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry\u002F immunofluorescence\u002F immunoelectron microscopy\u002F mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2\n* Mayo stage I-IIIA cardiac disease at Screening\n* Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.\n* Measurable hematologic disease: a dFLC \\>20 mg\u002FL with an abnormal κ\u002Fλ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g\u002FdL.\n* Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:\n* Absolute neutrophils ≥1,000\u002Fmm3,\n* Platelets ≥75,000\u002Fmm3,\n* Hemoglobin ≥8.5 g\u002FdL.\n* Adequate organ function, defined as:\n* Serum creatinine clearance (CKD-EPI formula) ≥20 mL\u002Fmin,\n* Serum SGPT\u002FALT \\\u003C5.0 x Upper Limit of Normal (ULN),\n* Serum total bilirubin \\\u003C2.0 mg\u002FdL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be \\\u003C2.0 mg\u002FdL,\n* Serum albumin ≥\\\u003C2.5 gr\u002Fdl (medication to correct serum albumin levels is permitted).\n\nExclusion Criteria:\n\n* Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.\n* Isolated soft-tissue involvement.\n* Presence of non-AL amyloidosis.\n* Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).\n* Intolerance to dexamethasone that would prohibit treatment with trial therapy.\n* MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.\n\nNote: A MM diagnosis with a serum FLC ratio \\>100, as the only myeloma-defining event, does NOT constitute an exclusion.\n\n* All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.\n* Mayo stage IIIB cardiac disease at Screening","ALL","18 Years",{"count":165,"type":166},30,"ESTIMATED","INTERVENTIONAL",[169],"PHASE2","This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab",[172],"AL Amyloidosis",[174],"teclistamab","2026-04-20",{"date":177,"type":178},"2026-04-21","ACTUAL",{"date":180,"type":178},"2025-07-02",{"date":182,"type":166},"2028-09",{"name":5,"class":6},10]