Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy

NCT ID: NCT00003341

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-12-31
• Study Completion Date: 2003-09-30

Brief Summary

RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best time for giving epoetin alfa during chemotherapy is not yet known.

PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are receiving chemotherapy.

Detailed Description

OBJECTIVES:

• Determine the hematologic response and transfusion requirements of patients with malignant lymphoma, chronic lymphocytic leukemia, or multiple myeloma with chemotherapy related moderate anemia treated with epoetin alfa.
• Determine the effect of moderate anemia on quality of life of these patients treated with this regimen.
• Correlate changes in quality of life with changes in anemia associated with treatment with epoetin alfa in these patients.
• Determine the effect of changing quality of life on health care resource utilization among these patients treated with epoetin alfa.

OUTLINE: This is a randomized, open label, multicenter study.

Patients are evaluated for anemia during their prescribed chemotherapy regimens at either 3 or 4 week intervals beginning week 3 or 4. Patients with hemoglobin levels of 10.0-12.0 g/dL are randomized to 1 of 2 treatment arms. Patients with hemoglobin levels greater than 12.0 g/dL are not randomized until their hemoglobin levels decrease to 12.0 g/dL or below.

• Arm I: Patients immediately receive epoetin alfa subcutaneously each week.
• Arm II: Patients are observed for 6-8 weeks and then hemoglobin levels are reevaluated. Patients whose hemoglobin levels decrease below 9.0 g/dL receive epoetin alfa subcutaneously each week. Patients whose hemoglobin levels are at least 9.0 g/dL are observed for another 3-4 weeks and then hemoglobin levels are reevaluated.

Patients receive epoetin alfa treatment for up to 15 or 16 weeks.

Qualify of life questionnaires are completed every 3 or 4 weeks until week 30 or 32.

Patients are followed through week 36.

PROJECTED ACCRUAL: A total of 275 patients (at least 130 per treatment arm) will be accrued for this study.

Conditions

Anemia; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

epoetin alfa

Intervention Type: BIOLOGICAL

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia, or multiple myeloma

• Low grade, intermediate grade, or high grade (diffuse large cell immunoblastic only) NHL OR
• Histologically confirmed Hodgkin's disease with prior chemotherapy
• Evaluable lesion
• Must be scheduled for at least 1 myelosuppressive cytotoxic regimen (experimental chemotherapy regimens allowed) for at least 4-6 months
• No anemia predominantly due to factors other than cancer or chemotherapy (i.e.,iron or folate deficiencies, hemolysis, or gastrointestinal bleeding) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 6 months

Hematopoietic:

• Transferrin saturation at least 20%
• Ferritin at least 50 ng/mL OR
• Adequate iron stores in bone marrow
• If transferrin saturation is less than 20% or ferritin is less than 50 ng/mL, investigator may utilize bone marrow evaluation results to determine whether iron stores are adequate
• Hemoglobin at least 10.0 g/dL

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No uncontrolled hypertension

Other:

• HIV negative
• No active, unresolved infection
• No hypersensitivity to mammalian cell derived products
• Must be able to read and understand English at a 6th grade level consistent with comprehending the quality of life questionnaires
• No other malignancy within past 5 years, except basal cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent epoetin alfa independent of protocol
• No concurrent interferons and interleukins (occasional short term use may be permitted on a case by case basis)
• No prior peripheral blood stem cell transplantation

Chemotherapy:

• See Disease Characteristics
• At least 2 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy

Surgery:

• Not specified

Other:

• At least 30 days since prior nonchemotherapy experimental agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

David J. Straus, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Comprehensive Cancer Centers of the Desert

Palm Springs, California, United States

Division of Oncology

Palo Alto, California, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Rush Cancer Institute

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MSKCC-97125

Identifier Type: -

Identifier Source: secondary_id

ORTHO-PR-96-27-031

Identifier Type: -

Identifier Source: secondary_id

RPCI-DS-97-38

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1436

Identifier Type: -

Identifier Source: secondary_id

97-125

Identifier Type: -

Identifier Source: org_study_id