Lymphoma Clinical Trial
Official title:
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
RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best
time for giving epoetin alfa during chemotherapy is not yet known.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating
anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are
receiving chemotherapy.
OBJECTIVES:
- 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
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