Multiple Myeloma Clinical Trial
Official title:
Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the
growth of abnormal cells by stopping them from dividing or killing them. Giving
colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells
move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and
monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell
transplant. The stem cells are then returned to the patient to replace the blood-forming
cells that were destroyed by the chemotherapy.
PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib
followed by stem cell transplant works in treating patients with primary systemic
amyloidosis.
OBJECTIVES:
- To determine if hematologic responses to high-dose melphalan and autologous stem cell
transplantation increase with addition of bortezomib in the conditioning regimen in
patients with primary systemic amyloidosis.
OUTLINE:
- Autologous stem cell mobilization and collection: Patients receive filgrastim (G-CSF)
to mobilize stem cells, which are then collected.
- Conditioning regimen: Patients receive bortezomib IV on days -6, -3, 1, and 4 and oral
high-dose melphalan on days -2 and -1.
- Stem cell transplantation: Patients undergo autologous stem cell transplantation on day
0.
After completion of study therapy, patients are followed every 6 months for 1 year and
annually thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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