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A Phase II Study of Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Systemic Light-Chain Amyloidosis
[Protocol 07-006]
- Full Title :
- RISK-ADAPTED INTRAVENOUS MELPHALAN WITH STEM CELL TRANSPLANT AND ADJUVANT BORTEZOMIB AND DEXAMETHASONE FOR RECENTLY DIAGNOSED UNTREATED PATIENTS WITH SYSTEMIC LIGHT-CHAIN (AL) AMYLOIDOSIS
- Purpose :
Amyloidosis is a disease caused by an abnormal protein made by a family of cells in the bone marrow called plasma cells. The purpose of this study is to evaluate the safety and effectiveness of three drugs -- melphalan, bortezomib, and dexamethasone -- used in combination with stem cell transplantation in patients with light-chain amyloidosis.
These three drugs have been shown to reduce plasma cells in "clonal" plasma cell diseases. The treatment in this study includes the initial use of melphalan given by vein, followed by a stem cell transplant. This treatment is an attempt to eliminate the clonal plasma cells that make the amyloid protein. It is hoped that this will help the body to slowly remove the amyloid from its organs, and will help the patient benefit from improved organ function and quality of life.
Only those patients who still have clonal plasma cells present two to three months after the stem cell transplant will receive the other two drugs, bortezomib and dexamethasone. Researchers want to see how well treatment with bortezomib and dexamethasone works to reduce remaining clonal plasma cell disease. The reduction or elimination of clonal plasma cells in patients with amyloidosis improves their well being and survival.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of light-chain amyloidosis that has affected no more than two of the following organ systems: kidneys, liver/digestive tract, peripheral/autonomic nervous system, or heart.
- Patients may not have received previous treatment for amyloidosis.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Heather Landau at 212-639-8808.
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