A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis
OBJECTIVES: I. Assess the response rate and overall survival of patients with biopsy proven
primary amyloidosis following treatment with myeloablative chemotherapy and hematopoietic
stem cell reconstitution. II. Evaluate the toxicity of high dose melphalan in this patient
population.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 1 of the
peripheral blood stem cell (PBSC) collection period and continuing until PBSC collection is
completed. PBSC are collected beginning on day 5 of the collection period and continuing
until the final target cell count is reached or for up to a maximum of 7 collections. If
sufficient PBSCs are not harvested within a maximum of 7 collections, the patient is removed
from the study. Within 30 days of PBSC collection, patients receive melphalan IV on day -1
of the infusion period and PBSC infusion on day 0. The infusion period continues until day
30. Patients receive G-CSF subcutaneously daily starting on day 1 and continuing until blood
counts recover. Patients are followed every 3 months for 2 years, every 3 months for 3
additional years, and yearly thereafter.
PROJECTED ACCRUAL: A maximum of 33 patients will be accrued for this study over 2 years.
Interventional
Primary Purpose: Treatment
Morie A. Gertz, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000066334
NCT00003353
July 1998
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |