Patients must have a diagnosis of biopsy-proven diagnosis of AL amyloidosis according to the following standard criteria:\r\n* Histochemical diagnosis of AL amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence and immunohistochemistry\r\n* If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary\r\n* Measurable disease as defined by serum differential free light chain concentration (dFLC, difference between amyloid forming [involved] and non amyloid forming [uninvolved] free light chain [FLC]) ? mg/L)\r\n* Systemic amyloid organ involvement including renal, cardiac, gastrointestinal (GI) and/or nervous system involvement as well as soft tissue disease
Untreated biopsy proven AL amyloidosis
Patients with known amyloidosis (AL) subtype amyloidosis
Non-secretory MM or known amyloid light-chain (AL) amyloidosis
Patients with known AL subtype amyloidosis
Patients with histologically-confirmed symptomatic multiple myeloma or AL amyloidosis undergoing autologous hematopoietic cell transplantation (HCT) with melphalan or mg/m^
Non-AL amyloidosis
Biopsy-proven histochemical diagnosis of amyloid light-chain (AL) amyloidosis based on tissue specimens with Congo red staining or other histologic stain; thioflavin T or S, or crystal violet; tandem mass spec or immunohistochemistry (IHC) confirmation of immunoglobulin-derived amyloidosis is encouraged; cases in which histochemical confirmation is lacking need to be discussed with one of the Multiple Myeloma Research Foundation (MMRF) protocol chair/co-chairs
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
Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following:
One or more organs impacted by AL amyloidosis according to consensus guidelines
Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD, with the exception of mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization
Non-secretory MM or known amyloid light-chain (AL) amyloidosis
Light chain (AL) amyloidosis patients with Mayo cardiac stage III (defined as N-terminal proB-type natriuretic peptide measurement [proBNP] > ng/L and cardiac troponin [cTnT] > . ug/L)
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 (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:
If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary.
Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis.
Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered to be investigational or which would be considered as a treatment of AL amyloidosis. However, participants may be on chronic steroids (maximum dose mg/day prednisone or equivalent) if they are being given for disorders other than amyloidosis (eg, adrenal insufficiency, rheumatoid arthritis, etc.).
Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis
Primary systemic AL (immunoglobulin light chain) amyloidosis
Biopsy-proven diagnosis of AL amyloidosis by immunohistochemistry or mass spectroscopy of a tissue biopsy excluding bone marrow
Screening renal biopsy for RAIN confirming AL amyloidosis as exclusive or dominant cause of renal damage
Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis
Patients who have not been treated or who have received chemotherapy within months, or SCT within months, for the light-chain producing hematologic disease causing AL amyloidosis, at the time of the first dose of NEOD (month day )
Patients whose screening renal biopsies for RAIN show dominant causes of renal damage not related to AL amyloidosis
Patients must have a confirmed diagnosis of amyloid light-chain (AL) amyloidosis based on accepted clinical and laboratory criteria
Non-AL amyloidosis
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;
Primary systemic amyloid light (AL) chain amyloidosis (a build-up of amyloid light chain proteins in the blood)
Newly diagnosed, AL amyloidosis treatment nave
Confirmed diagnosis of AL amyloidosis
Non-AL amyloidosis
Confirmed diagnosis of systemic AL amyloidosis
Non-AL amyloidosis
Histologically-proven AL amyloidosis, confirmed by positive Congo red stain with green birefringence on polarized light microscopy with evidence of measurable clonal disease that requires active treatment as defined below:
Light-chain (AL) amyloidosis; patients with secondary amyloidosis due to MM are eligible
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.
Histological diagnosis of AL amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens; the type must have been confirmed unequivocally
Receiving any other investigational agent which would be considered as a treatment for AL amyloidosis
Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis