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
- 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
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
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Efficacy of epoetin alfa as measured by hematologic response and transfusion requirements
Ronald M. Sobecks, MD
Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|