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Matteo\"","Pavia","Italy","IT",{"type":40,"coordinates":137},[138,139],9.15917,45.19205,{"lat":139,"lon":138},[142],{"name":143,"role":28,"phone":30,"phoneExt":30,"email":30},"Palladini",{"facility":145,"status":35,"city":146,"state":30,"zip":30,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"UMC Utrecht","Utrecht","Netherlands","NL",{"type":40,"coordinates":150},[151,152],5.12222,52.09083,{"lat":152,"lon":151},[155],{"name":156,"role":28,"phone":30,"phoneExt":30,"email":30},"Minnema",{"type":158,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[160],{"name":161,"class":162},"Janssen Research & Development","UNKNOWN","100566016","phase-2-a-phase-ii-trial-of-teclistamab-in-participants-with-previously-treated-immunoglobulin-light-chain-al-amyloidosis-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":172,"type":173},30,"ESTIMATED","INTERVENTIONAL",[176],"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",[179],"AL Amyloidosis",[181],"teclistamab","2026-04-20",{"date":184,"type":185},"2026-04-21","ACTUAL",{"date":187,"type":185},"2025-07-02",{"date":189,"type":173},"2028-09",{"name":5,"class":6},10]