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Amyloid Light Chain

Criteria to qualify for study: Drug used in study:
  • Light Chain
  • Patients must have a confirmed diagnosis of AL amyloid by histochemical (congo red-stain) AND confirmatory immunohistochemistry or mass spectrometry
  • Patients must have confirmed diagnosis of AL amyloidosis by mass spectrometry if they are black or African American, is over 75 years of age, or has a history of familial amyloidosis and hss concurrent monoclonal gammopathy
  • Patients cannot be eligible for or plan to undergo ASCT

AMY 01 NEOD001-CL002 Prothena

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis


Criteria to qualify for study: Drug used in study:
  • Untreated
  • Serum M protein must be at least 0.5 g/dL
  • Urine M proteint must be at least 200 mg/24hr
  • A difference between the involved IG free light chain and uninvolved light chain of at least 5 mg/dL AND abnormal serum IG kappa lambda free light chain ratio
  • ANC must be at least 1000
  • PLT must be at least 75

CBCI-248 Karmanos 2011-155

Phase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition Disease



Criteria to qualify for study: Drug used in study:
  • Previously Treated
  • Placebo controlled
  • No chemotherapy or radiation within 6 months prior to starting therapy
AMY 03 – NEOD001
A Phase 2b, Randomized, Double-Blind, Placebo-controlled study of NEOD0001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction.