A Phase II Study of Bendamustine and Dexamethasone in Patients with Relapsed Amyloidosis

Protocol
12-257
Full Title
Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients with Relapsed AL Amyloidosis
Phase
II
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.

In this study, researchers are evaluating the safety and effectiveness of combining bendamustine (a drug approved for treating chronic lymphocytic leukemia and non-Hodgkin lymphoma) and dexamethasone (a steroid commonly used as part of cancer therapy) in patients with amyloidosis that has returned despite prior therapy. Other studies have suggested that this combination of drugs may be effective for these patients.

Bendamustine is given intravenously (by vein) and dexamethasone 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 amyloidosis or light-chain deposition disease that persists despite at least one regimen of chemotherapy and/or a stem cell transplant.
  • Patients who have not had a stem cell transplant may participate in this study only if they are ineligible for or have declined transplantation.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • 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.

Disease(s)
Hematology: Hematologic Disorders
Hematology: Hematologic Malignancies
Locations