A Phase 3 Randomized Multicenter Double-Blind Placebo-Controlled Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Light Chain (al) Amyloidosis
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
1) Newly diagnosed and AL amyloidosis treatment naive (Mayo Stage IV). 2) Bone marrow demonstrating clonal plasma cells. 3) Confirmed diagnosis of AL amyloidosis by the following: histochemical diagnosis of amyloidosis determined by polarizing light microscopy of green birefringent material in Congo red-stained tissue specimens or characteristic electron microscopy appearance and confirmatory immunohistochemistry or mass spectroscopy of AL amyloidosis.
You may not be eligible for this study if the following are true:
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1) Non-AL amyloidosis. 2) NT-proBNP >8500 pg/mL. 3) Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma. 4) Subject is eligible for and plans to undergo ASCT or organ transplant during the study.
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