Diagnosis of amyloidosis
Subjects with known or suspected amyloidosis of any organ
Pts with primary systemic amyloidosis
Untreated biopsy proven AL amyloidosis
Patients with multi-organ involvement by amyloidosis or evidence of amyloidosis-related organ dysfunction
Patients with known amyloidosis (AL) subtype amyloidosis
Known amyloidosis (MM patients)
Patients with known AL subtype amyloidosis
Non-AL amyloidosis
Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis; exception: patients with amyloid heavy (AH) or mixed AL/AH type amyloidosis are potentially eligible
Central nervous system involvement with disease under study (myeloma), or concurrent AL amyloidosis or plasma cell leukemia
Primary amyloidosis (AL) or myeloma complicated by amyloidosis
One or more organs impacted by AL amyloidosis according to consensus guidelines
Known or suspected amyloidosis
Patients with primary systemic amyloidosis
Subject medically diagnosed with AL amyloidosis that has required chemotherapy or an autologous stem cell transplant based upon: AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type, in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded
Newly diagnosed AL amyloidosis based upon: AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded
Fulfilment of diagnostic criteria for AL amyloidosis
Primary amyloidosis
Amyloidosis
Patients with non-secretory MM or known primary amyloidosis are not eligible
Diagnosis of amyloidosis
Primary amyloidosis (AL) or myeloma complicated by amyloidosis
Presence of primary or associated amyloidosis (AL)
Biopsy-proven diagnosis of primary systemic light chain amyloidosis (AL amyloidosis) according to the following standard criteria:
Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis.
Primary amyloidosis
Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis
Patients with non-secretory MM or known amyloidosis are not eligible
Amyloidosis
Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis
History of or current amyloidosis
Non-AL amyloidosis
Subjects with known or likely systemic amyloidosis
No primary amyloidosis
Amyloidosis
Subjects with known or likely systemic amyloidosis
Subjects with known or suspected amyloidosis of any organ
Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible);
Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis;
Secondary or familial amyloidosis;
Primary amyloidosis
Any form of secondary / familial amyloidosis
Amyloidosis
Newly diagnosed, AL amyloidosis treatment naïve
Confirmed diagnosis of AL amyloidosis
Non-AL amyloidosis
Confirmed diagnosis of systemic AL amyloidosis
Non-AL amyloidosis
Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
Patients with known amyloidosis
Patients with known amyloidosis
Known amyloidosis
Light-chain (AL) amyloidosis; patients with secondary amyloidosis due to MM are eligible
Patients with primary systemic amyloidosis.
Patients with known amyloidosis.
Primary AL amyloidosis
Primary AL amyloidosis
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
Receiving any other investigational agent which would be considered as a treatment for AL amyloidosis
Amyloidosis