Renal AL Amyloid Involvement and NEOD001

Exclusion Criteria

• •1. Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis
• •2. Female patients who are lactating, breastfeeding, or pregnant
• •3. Patients who have not been treated or who have received chemotherapy within 6 months, or SCT within 12 months, for the light-chain producing hematologic disease causing AL amyloidosis, at the time of the first dose of NEOD001 (month 1 day 1)
• •4. Patients who at initial diagnosis or later met the International Myeloma Working Group (IMWG) definition of active multiple myeloma requiring therapy (Appendix 3)
• •5. Patients whose screening renal biopsies for RAIN show dominant causes of renal damage not related to AL amyloidosis
• •6. Medically documented cardiac syncope, uncompensated congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive atrial or ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically significant uncompensated autonomic insufficiency
• •7. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• •8. Ongoing or active infection, known HIV positive, known to be hepatitis B surface antigen-positive or has known or suspected active hepatitis C infection.
• •9. Psychiatric illness/social situations that would limit compliance with study requirements