A Phase II Study of Ixazomib as Maintenance Therapy in Patients with Light Chain Amyloidosis

Full Title

MCT: Ixazomib Maintenance Following Initial Therapy in Patients with Immunoglobulin Light Chain (AL) Amyloidosis

Purpose

Amyloidosis is a cancer of bone marrow plasma cells. The plasma cells make abnormal, misfolded amyloid proteins that build up in tissues and organs, preventing them from working properly. The heart, kidneys, digestive tract, liver, and nervous system are often involved. While there is no cure, treatment with chemotherapy can stop the growth of abnormal cells that produce amyloid protein and, over time, damaged organs can improve.

A certain class of medications has been shown to be effective in patients with amyloidosis. Ixazomib is a drug that belongs to this class of medications. It has been shown to be effective in patients with amyloidosis whose disease has not responded to or progressed despite other therapies. In this study, researchers want to see if ixazomib can be used as a maintenance treatment to prevent or delay disease relapse in patients with light chain amyloidosis that has responded well to initial therapy. Ixazomib is taken orally (by mouth).

Eligibility

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

  • Patients must have light chain amyloidosis that responded at least partially to induction therapy.
  • Patients should have had at least two cycles of induction therapy and must enter the study within a year of starting that treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • 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 212-639-8808.

Protocol

18-069

Phase

II

Investigator

Co-Investigators