Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
- Conditions
- AnemiaLeukemiaLymphomaMultiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00003341
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Comprehensive Cancer Centers of the Desert
🇺🇸Palm Springs, California, United States
Division of Oncology
🇺🇸Palo Alto, California, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Rush Cancer Institute
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Scroll for more (8 remaining)Alta Bates Comprehensive Cancer Center🇺🇸Berkeley, California, United States