Multiple Myeloma Clinical Trial
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
Summary
OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation.
II. Determine the toxicity of this regimen in these patients.
Full Description
PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days.
Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and continuing until blood counts recover. This course may be repeated 4-12 weeks later.
Patients are followed every 3 months for 1 year and then annually for 5 years.
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
Disease Characteristics
Histologically confirmed primary amyloidosis
Ineligible for other high priority national or international study
Prior/Concurrent Therapy
Biologic therapy: Concurrent participation in gene therapy trials allowed
Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy
Endocrine therapy: No concurrent steroids unless given with amphotericin B, for adrenal failure, or for septic shock No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes)
Other: No concurrent barbiturates or acetaminophen Concurrent participation in supportive care trials allowed
Patient Characteristics
Performance status: ECOG 0-3
Hepatic: Bilirubin less than 2 times normal
Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis
Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist
Other: HIV negative
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There is 1 Location for this study
New York New York, 10032, United States
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