NCT00003341

Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	epoetin alfa
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 1997-12-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2003-04-25
• Last updated: 2013-07-03

Locations

18 sites across 1 country: United States