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

Not Applicable

Completed

• Conditions: Anemia; Multiple Myeloma; Plasma Cell Neoplasm
• Interventions: Biological: epoetin alfa

• Registration Number: NCT00400686
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Primary Completion: 2009-01
• Study Completion: 2013-08
• Results First Submitted: 2015-06-03
• Results First Submitted QC: 2016-10-18
• Results First Posted: 2016-12-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Alfa - 80,000 U sc	epoetin alfa	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

Primary Outcome Measures

Name	Time	Method
Number of Patients With an at Least 1gm/dL Increase in Hgb	Baseline to Day 28
Number of Patients With an at Least 2gm/dL Increase in Hgb	Baseline to Day 28
Change From Baseline in Hemoglobin at Day 28	Baseline to Day 28	Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.

Trial Locations

Locations (1)

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States