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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa

Criteria

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.