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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00003341

Collaborator

National Cancer Institute (NCI) (NIH)

275

Enrollment

Locations

Duration (Months)

15.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm	Biological: epoetin alfa Procedure: quality-of-life assessment	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

275 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Study Start Date :

Dec 1, 1997

Actual Primary Completion Date :

Sep 1, 2003

Actual Study Completion Date :

Sep 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
2	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
3	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
4	Comprehensive Cancer Centers of the Desert	Palm Springs	California	United States	92262
5	Division of Oncology	Palo Alto	California	United States	94304
6	George Washington University Medical Center	Washington	District of Columbia	United States	20037
7	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
8	Rush Cancer Institute	Chicago	Illinois	United States	60612
9	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
10	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
11	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
12	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
13	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
14	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
15	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
16	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
17	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
18	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009