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

Sponsor

Ortho Biotech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00524407

Collaborator

(none)

273

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Anemia Cancer	Drug: Epoetin alfa	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

273 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 1996

Actual Study Completion Date :

Nov 1, 2002

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.