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	Treatment or Intervention	Phase
Lymphoma Leukemia Multiple Myeloma	Procedure: supportive care  Drug: hematologic toxicity attenuation  Procedure: complications of therapy assessment/management  Behavior: supportive care/therapy  Procedure: quality-of-life assessment  Drug: epoetin alfa	Phase III

Further Study Details: 

OBJECTIVES: I. 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. II. Determine the effect of moderate anemia on quality of life of these patients treated with this regimen. III. Correlate changes in quality of life with changes in anemia associated with treatment with epoetin alfa in these patients. IV. Determine the effect of changing quality of life on health care resource utilization among these patients treated with epoetin alfa.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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.]

--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

--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

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

Study chairs or principal investigators

David J. Straus,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000066316; MSKCC-97125; NCI-G98-1436; ORTHO-PR-96-27-031; RPCI-DS-97-38
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003341
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08