Effect of Epoetin Alfa on Hemoglobin, Symptom Distress, and Quality of Life in Patients Receiving Chemotherapy

April 1, 2010 updated by: Ortho Biotech, Inc.

The Effects of PROCRIT (Epoetin Alfa) on Hemoglobin, Symptom Distress, and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia

The purpose of this study was to compare the effectiveness of epoetin alfa treatment on hemoglobin (Hb) response, quality of life (QoL), health care resource utilization and patient productivity when epoetin alfa was administered during chemotherapy to patients with mild anemia or after waiting until patients became moderately anemic. Patients with lymphoma, chronic lymphocytic leukemia (CLL) or Multiple Myeloma (MM) were studied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was an open-label (patients and investigators knew what treatment was being given), randomized (patients were assigned to a treatment group by chance) study of lymphoma, chronic lymphocytic leukemia (CLL), or multiple myeloma patients. This study addressed the clinical and patient-management consequences of treating mild to moderate anemia (hemoglobin (Hb) between 10 and 12 g/dL). The design of the study compared the effect of treating higher Hb levels to current standard of care criteria on Hb levels, transfusion requirements, and patient reported outcomes (quality of life, health care resource utilization, and productivity). Patients were randomized according to their Hb levels. Two entry criteria were specified during the course of the trial. Initially, patients were enrolled with Hb levels >= 11 g/dL and then randomized to receive 1) Immediate epoetin alfa treatment or 2) Observed after Hb levels fell below 11 g/dL. Epoetin alfa treatment was provided to the Observed group if and when Hb levels fell below 9.0 g/dL. Slow recruitment of patients in to the study resulted in a protocol amendment. Subsequently, if a patient presented with a Hb between 10 and 12 g/dL, the patient was randomized to the Immediate or to the Observed groups. Patients presenting with Hgb > 12 g/dL but otherwise eligible, were not randomized until Hb dropped to <=12 g/dL. Patients remained in the study for up to 36 weeks. Safety assessments were performed throughout the study and included obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. The starting dose of PROCRIT (Epoetin alfa) was administered subcutaneously (sc) as 40,000 Units (U) once weekly (qw). If after 3-4 weeks of therapy, the Hb did not increase by > 1.0 g/dL, the dose was increased to 60,000 U sc qw. If at any time, the Hb rose above 15 g/dL on 2 consecutive evaluations, PROCRIT (Epoetin alfa) was stopped until the Hb dropped to below 13 g/dL and then resumed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must present with non-Hodgkins Lymphoma (Low, Intermediate or High Grade) or Hodgkins Disease, CLL or Multiple Myeloma
  • Life expectancy > 6 months with Karnofsky Performance Index of > =70
  • Evaluable lesion as objective indicator of response
  • Scheduled for at least one myelosuppressive cytotoxic regimen (experimental chemotherapy allowed) for at least 4-6 months
  • Patients with reproductive potential must have used an adequate contraceptive method
  • Transferrin saturation = 20% and serum ferritin = 50 ng/mL Bone marrow evaluations may be performed to determine if iron stores are adequate
  • histologic documentation of disease.

Exclusion Criteria:

  • Patients with no second active malignancy or history of other malignancy diagnosed within preceding 5 years (other than basal cell carcinoma or cervical cancer)
  • No uncontrolled hypertension
  • active, unresolved infection
  • anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, hemolysis, or GI bleeding
  • Receiving Epoetin alfa independent of protocol
  • Received chemotherapy with the previous 14 days
  • Prior total lymphoid, extensive abdominal or inverted Y radiation therapy
  • No use of interferons or interleukins during study
  • No use of nonchemotherapy experimental agents within preceding 30 days
  • No Hodgkins Disease patients who are chemotherapy naïve
  • Received stem cell transplant.

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To measure the change in quality of life score as demonstrated by the FACT-An (Functional Assessment in Cancer Therapy - Anemia) and LASA (Linear Analogue Assessment Scale) tools over the 36 week study period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Health care resource utilization. To measure transfusion requirements and change in Hb levels. All patients were followed for survival until closure of study which was the time the last patient in the entire study completed study participation.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ortho Biotech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ortho Biotech, Inc. Clinical Trial, Ortho Biotech, Inc.

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 1996

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR005125

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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