NCT00400686

Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia
• Multiple Myeloma
• Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	epoetin alfa	Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.

Timeline

• Start date: 2003-09-01
• Primary completion: 2009-01-01
• Completion: 2013-08-01
• First posted: 2006-11-17
• Last updated: 2018-02-22
• Results posted: 2016-12-09

Locations

1 site across 1 country: United States