Multiple Myeloma Clinical Trial
Official title:
High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer
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 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 the side effects of high-dose melphalan given
together with stem cell transplant and to see how well it works in treating patients with
immunoglobulin deposition disease or light-chain deposition disease.
OBJECTIVES:
- To assess the tolerability of high-dose melphalan and autologous stem cell
transplantation in patients with immunoglobulin deposition disease or light-chain
deposition disease.
- To determine the hematologic response rate in patients treated with this regimen.
- To determine the predictability of early free light-chain response for heme response in
patients treated with this regimen.
- To determine organ or clinical response in patients treated with this regimen.
- To determine overall survival of these patients.
OUTLINE:
- Stem cell mobilization: Patients undergo blood stem cell mobilization comprising
filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before
the last stem cell collection).
- Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells
until the target number of stem cells (at least 2 x 10^6 CD34+ cells) is reached.
- Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2.
- Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day
0.
After completion of study therapy, patients are followed at 3, 6, and 12 months and then
annually thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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