A Phase II Study of Isatuximab in Patients with Previously Treated Amyloidosis

Full Title

A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients with Previously Treated AL Amyloidosis (CIRB) (S1702)

Purpose

Amyloidosis is a disorder in which abnormal proteins build up in tissues and organs. Clumps of the abnormal proteins are called amyloid deposits. Amyloidosis may be treated with chemotherapy, but the disease often returns.

The purpose of this study is to assess the safety and effectiveness of the investigational drug isatuximab in patients with amyloidosis that persists despite prior treatment. Isatuximab has been shown to have good effects in some patients with recurrent multiple myeloma; researchers think that isatuximab may also help patients whose amyloidosis has come back or gotten worse. It works by targeting a protein involved in amyloidosis growth called CD38.

Isatuximab is given intravenously (by vein).

Eligibility

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

  • Patients must have systemic light chain amyloidosis that persists or has returned despite at least one prior regimen of therapy.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Heather Landau at 212-639-8808.

Protocol

18-358

Phase

II

Investigator

Co-Investigators