a phase ii trial of teclistamab in participants with previously treated immunoglobulin light-chain (al) amyloidosis

Conditions: AL Amyloidosis

Summary: 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


Eligibility criteria:
inclusion criteria: * histologic diagnosis of al amyloidosis and typed with immunohistochemistry/ 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. * genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry/ immunofluorescence/ immunoelectron microscopy/ 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. * eastern cooperative oncology group (ecog) performance status 0,1 or 2 * mayo stage i-iiia cardiac disease at screening * 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. * measurable hematologic disease: a dflc \>20 mg/l with an abnormal κ/λ ratio (with freelite® test kits, the binding site) or presence of a monoclonal spike ≥0.5 g/dl. * adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (c1d1), defined as: * absolute neutrophils ≥1,000/mm3, * platelets ≥75,000/mm3, * hemoglobin ≥8.5 g/dl. * adequate organ function, defined as: * serum creatinine clearance (ckd-epi formula) ≥20 ml/min, * serum sgpt/alt \<5.0 x upper limit of normal (uln), * serum total bilirubin \<2.0 mg/dl or direct bilirubin ≤30% of the total, unless the patient has gilbert's syndrome, where direct bilirubin should then be \<2.0 mg/dl, * serum albumin ≥\<2.5 gr/dl (medication to correct serum albumin levels is permitted). exclusion criteria: * 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. * isolated soft-tissue involvement. * presence of non-al amyloidosis. * previous anti-bcma targeted therapy (including, but not limited to, bispecifics). * intolerance to dexamethasone that would prohibit treatment with trial therapy. * 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. note: a mm diagnosis with a serum flc ratio \>100, as the only myeloma-defining event, does not constitute an exclusion. * 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. * mayo stage iiib cardiac disease at screening

Keywords: teclistamab