Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
Phase II Trial of Second Autologous Transplantation in 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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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