A Phase III Study of Amyloidosis Treatment with or without CAEL-101 in People with Previously Untreated Mayo Stage IIIb Light Chain Amyloidosis

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A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis (WIRB)

Purpose

Amyloidosis is a condition that arises from bone marrow plasma cells. The plasma cells make abnormal, misfolded amyloid proteins that build up in tissues and organs, preventing them from working properly. Amyloidosis can damage the heart and other organs.

In this study, researchers are evaluating the effectiveness of adding the investigational drug CAEL-101 to standard therapy in patients with previously untreated Mayo stage IIIb “light chain” amyloidosis. CAEL-101 binds specifically to the light chains (kinds of proteins) that make up amyloid protein deposits. The body’s natural defenses can then find the protein deposits and destroy them.

Patients in this study will be randomly assigned to receive CAEL-101 or a placebo in addition to their standard amyloidosis therapy. CAEL-101 is given intravenously (by vein). Researchers hope that adding CAEL-101 to standard treatment will help people with heart damage from amyloidosis to live longer.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated Mayo stage IIIb light chain amyloidosis.
  • Patients must have evidence of heart damage due to amyloidosis.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Heather Landau at 646-608-3740.

Protocol

21-058

Phase

III

Investigator

Co-Investigators