The Effects of Procrit (Epoetin Alfa) on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Patients With Mild to Moderate Anemia A Multicenter Trial
- Determine the hematologic response and transfusion requirements of patients with
malignant lymphoma, chronic lymphocytic leukemia, or multiple myeloma with chemotherapy
related moderate anemia treated with epoetin alfa.
- Determine the effect of moderate anemia on quality of life of these patients treated
with this regimen.
- Correlate changes in quality of life with changes in anemia associated with treatment
with epoetin alfa in these patients.
- Determine the effect of changing quality of life on health care resource utilization
among these patients treated with epoetin alfa.
OUTLINE: This is a randomized, open label, multicenter study.
Patients are evaluated for anemia during their prescribed chemotherapy regimens at either 3
or 4 week intervals beginning week 3 or 4. Patients with hemoglobin levels of 10.0-12.0 g/dL
are randomized to 1 of 2 treatment arms. Patients with hemoglobin levels greater than 12.0
g/dL are not randomized until their hemoglobin levels decrease to 12.0 g/dL or below.
- Arm I: Patients immediately receive epoetin alfa subcutaneously each week.
- Arm II: Patients are observed for 6-8 weeks and then hemoglobin levels are reevaluated.
Patients whose hemoglobin levels decrease below 9.0 g/dL receive epoetin alfa
subcutaneously each week. Patients whose hemoglobin levels are at least 9.0 g/dL are
observed for another 3-4 weeks and then hemoglobin levels are reevaluated.
Patients receive epoetin alfa treatment for up to 15 or 16 weeks.
Qualify of life questionnaires are completed every 3 or 4 weeks until week 30 or 32.
Patients are followed through week 36.
PROJECTED ACCRUAL: A total of 275 patients (at least 130 per treatment arm) will be accrued
for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
David J. Straus, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|George Washington University Medical Center||Washington, District of Columbia 20037|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Comprehensive Cancer Centers of the Desert||Palm Springs, California 92262|
|Alta Bates Comprehensive Cancer Center||Berkeley, California 94704|
|Division of Oncology||Palo Alto, California 94304|
|Rush Cancer Institute||Chicago, Illinois 60612|