Second Autologous Stem Cell Transplant in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis
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.
Multiple Myeloma and Plasma Cell Neoplasm
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Second Autologous Transplantation in AL Amyloidosis|
- Feasibility and tolerability [ Time Frame: 3 months after treatment and annually ] [ Designated as safety issue: Yes ]
- Response and durability of response [ Time Frame: 3 months after treatment and annually ] [ Designated as safety issue: No ]
- Evaluate immune reconstitution [ Time Frame: 3 months after treatment and annually ] [ Designated as safety issue: No ]
|Study Start Date:||August 2001|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075608
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Karen Quillen, MD||Boston Medical Center|