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Brief Title: 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Official Title: Phase II Trial of Second Autologous Transplantation in AL Amyloidosis
Study ID: NCT00075608
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly. PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
Detailed Description: OBJECTIVES: * Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis. * Determine the response rate and durability of response in patients treated with this regimen. * Determine immune reconstitution in patients treated with this regimen. OUTLINE: * Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection. * Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. * Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0. Patients are followed at 6 months, 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Boston University Cancer Research Center, Boston, Massachusetts, United States
Name: Karen Quillen, MD
Affiliation: Boston Medical Center
Role: PRINCIPAL_INVESTIGATOR