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Treatment for Patients with Light Chain (AL) Amyloidosis

Title AL Amyloidosis - Examining Tolerated Dose of NEOD001
Therapeutic Area Amyloidosis
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender Both
Contact George Mensing


The purpose of this study is to determine the maximum tolerated dose of the study drug NEOD001 when administered intravenously in AL amyloidosis participants.

Study Details

Inclusion Criteria

  • Must have systemis AL amyloidosis 
  • Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis 
  • Must have adequate organ function

Exclusion Criteria

  • Must not have Secondary or familial amyloidosis  
  • Must not have Symptomatic multiple myeloma defined as meeting one of the following: a. Lytic lesion on skeletal survey or hypercalcemia and b. Plasmacytoma 
  • You are an appropriate candidate for transplant, in the investigator’s opinion.

Study Requirements

This study consists of two phases. The dose escalation phase of the study, participants will be given different doses of the study drug. The expansion phase, participants will be given the highest tolerated dose of the study drug that was reached in the dose escalation phase. The study involves physical exams, blood draws, CT or MRI scans, urine samples, taking samples of your fat with a needle, as well as some other tests.
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