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Trial Summary

Protocol No.NEOD001-OLE251
StatusOPEN TO ACCRUAL
Principal InvestigatorAbonour, Rafat
Scope
PhasePhase II
Age GroupAdult
TitleA Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
DescriptionThe objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who have completed Study NEOD001-201.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Completed the End of Study Visit in Study NEOD001-201
  • Adequate bone marrow reserve, hepatic and renal function, as demonstrated by:
    • Absolute neutrophil count (ANC) ≥1.0 ? 109/L
    • Platelet count ≥75 ? 109/L
    • Hemoglobin ≥9 g/dL
    • Total bilirubin ≤2 ? upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) ≤3 ? ULN
    • Alanine aminotransferase (ALT) ≤3 ? ULN
    • Alkaline phosphatase (ALP) ≤5 ? ULN (except for subjects with hepatomegaly and isozymes specific to liver, rather than bone)
    • Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, or measured GFR ≥25 mL/min/1.73 m2
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesMultiple Myeloma
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactAnita L Rush-Taylor, RNPhone: 317-278-6797
Pager: 317-312-1108
Email: