Presence of an amyloid-related systemic syndrome |
(e.g., renal, liver, heart, gastrointestinal tract or peripheral nerve involvement- The organ damage must be felt to be related to amyloid deposition and not to another common disease, such as diabetes or hypertension) |
Positive amyloid staining by Congo red in any tissue (e.g., fat aspirate, bone marrow or organ biopsy) |
Evidence that the amyloid is light chain-related established by direct examination of the amyloid using spectrometry-based proteomic analysis or immunoelectron microscopy |
Evidence of a monoclonal plasma cell proliferative disorder (e.g., presence of a serum or urine M protein, abnormal serum free light chain ratio, or clonal plasma cells in the bone marrow) |