Spots Global Cancer Trial Database for Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
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
Study ID: NCT00003341
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: David J. Straus, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
