Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma
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:||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|
- Change From Baseline in Hemoglobin at Day 28 [ Time Frame: Baseline to Day 28 ]Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
- Number of Patients With an at Least 1gm/dL Increase in Hgb [ Time Frame: Baseline to Day 28 ]
- Number of Patients With an at Least 2gm/dL Increase in Hgb [ Time Frame: Baseline to Day 28 ]
|Study Start Date:||September 2003|
|Study Completion Date:||August 2013|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Epoetin Alfa - 80,000 U sc
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
Biological: epoetin alfa
Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400686
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Ronald M. Sobecks, MD||Case Comprehensive Cancer Center|