The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma

May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing the transfusion requirements in anemic patients with multiple myeloma, and to investigate the quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancer patients often experience anemia due to the disease itself, chemotherapy or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week randomized, double-blind, placebo-controlled, multicenter study (with an open-label extension) to assess the effectiveness of treatment with epoetin alfa in reducing the need for red cell transfusion by improving anemia in patients with multiple myeloma whose hemoglobin is less than 11 grams per deciliter. There will be 4 groups of patients in the study. Patients will first be placed into 2 groups according to whether or not they received at least 1 blood transfusion within the previous 3 months. Within each of these 2 groups, patients will then be randomly assigned to receive either epoetin alfa or placebo for 12 weeks. Dosing is initiated at 150 units per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks, then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. All patients who complete the 12-week double-blind period will be eligible to continue receiving epoetin alfa for an additional 12 weeks in an open-label extension of the study. The primary measures of effectiveness will be determined by the number of units of blood transfused, the proportion of patients requiring transfusion, and the number of units transfused relative to whether or not they received transfusions before the study. Additional effectiveness measures include the number of patients whose hemoglobin level reach at least 12 grams per deciliter (anemia considered "corrected") or who have an increase in hemoglobin of at least 2 grams per deciliter, and the change in the percentage of red blood cells and number of developing red blood cells in the blood. Changes in quality-of-life (Nottingham and visual analog scale) and performance scores will also be measured. Safety evaluations (incidence of adverse events, laboratory tests, and vital signs) and changes in underlying multiple myeloma will be assessed. The hypothesis of the study is that epoetin alfa will be superior to placebo in reducing the need for transfusions and improving anemia and quality of life. Double-blind: Epoetin alfa 150 units per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label: dose to maintain target hemoglobin range.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with documented multiple myeloma defined by standard criteria, with at least 6 months having elapsed since beginning chemotherapy
  • having a self-care performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a score ranging from 0 [fully active, no disease restriction] to 3 [capable of only limited self-care, confined to bed or chair more than 50% of waking hours])
  • having a life expectancy of at least 3 months
  • having a baseline hemoglobin <11 g/dL and baseline count of <100,000 microliter for developing red cells
  • with an ability to administer self-injections

Exclusion Criteria:

  • Patients having clinically significant disease other than cancer
  • having evidence of uncontrolled hypertension or a history of seizure
  • having untreated iron, folate, or Vitamin B12 deficiency
  • receiving a transfusion within 7 days of study entry, or androgen therapy within 1 month of study entry
  • receiving dialysis at baseline screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients requiring transfusion and number of units transfused relative to whether or not patients received transfusion(s) before the study.

Secondary Outcome Measures

Outcome Measure
Increase in hemoglobin, hematocrit, developing red blood cells in the blood; Changes in quality-of-life; Safety evaluations (incidence of adverse events, laboratory tests, and vital signs) including changes in underlying multiple myeloma.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1995

Study Completion (Actual)

September 1, 1996

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 26, 2005

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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