Multiple Myeloma Clinical Trial
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
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.
OBJECTIVES:
Primary
- Determine the hematologic response and transfusion requirements of chemotherapy-related
moderate anemia to the administration of a high initial dose of epoetin alfa followed by
a less frequent maintenance dose of epoetin alfa in multiple myeloma patients.
Secondary
- 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.
;
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