Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma
Recruitment status was Active, not recruiting
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia in patients with multiple myeloma.
PURPOSE: This clinical trial is studying how well epoetin alfa works in treating anemia in patients undergoing chemotherapy for multiple myeloma.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Single Institution, Open-Label, Nonrandomized Pilot Study of High Dose Epoetin Alfa Administered Once a Week in Patients With Multiple Myeloma: Its Effects on Hemoglobin, Blood Transfusion Requirements and Quality of Life|
- Efficacy of epoetin alfa as measured by hematologic response and transfusion requirements [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Quality of life as assessed by the Functional Assessment of Cancer Therapy Scales for Anemia (FACT-An) at baseline and at 4, 8, 16, and 24 weeks during treatment [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Biological: epoetin alfa
- Determine the efficacy of high-dose epoetin alfa followed by maintenance epoetin alfa in treating moderate anemia, in terms of hematologic response and transfusion requirements, in patients who are undergoing chemotherapy for multiple myeloma.
- Determine the effect of moderate anemia on quality of life in these patients.
- Correlate changes in hemoglobin levels with changes in quality of life in patients treated with this drug.
- Determine the effect of this drug on transfusion requirements after day 28 in these patients.
OUTLINE: This is an open-label, non-randomized, pilot study.
Patients receive high-dose epoetin alfa subcutaneously (SC) once a week for 4 weeks or until their hemoglobin levels reach 12-13 g/dL. Patients then receive epoetin alfa SC once every 2 weeks for 8 weeks OR once a week for 4 weeks, and then once every 2 weeks for 8 weeks (as long as their hemoglobin levels remain between 12-13 g/dL). Patients then receive maintenance epoetin alfa SC once every 4 weeks for up to 12 weeks.
Patients whose hemoglobin level decreases by 1-1.5 g/dL return to previous epoetin alfa schedule. Patients whose hemoglobin level is < 9 g/dL after returning to the previous schedule may receive epoetin alfa for an additional 24 weeks.
Quality of life is assessed at baseline and at weeks 2, 4, 8, 16, and 24 weeks during treatment.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Ronald M. Sobecks, MD||Case Comprehensive Cancer Center|