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

Lymphoma Clinical Trial

Official title:

The Effects of Procrit (Epoetin Alfa) on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Patients With Mild to Moderate Anemia A Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003341
• Other study ID #: 97-125
• Secondary ID: MSKCC-97125ORTHO
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 1, 2013
• Start date: December 1997
• Est. completion date: September 2003

Study information

• Verified date: July 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• epoetin alfa

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush Cancer Institute	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	Division of Oncology	Palo Alto	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	George Washington University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,