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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003341
First received: November 1, 1999
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 275
Study Start Date: December 1997
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003341

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003341     History of Changes
Other Study ID Numbers: 97-125, MSKCC-97125, ORTHO-PR-96-27-031, RPCI-DS-97-38, NCI-G98-1436
Study First Received: November 1, 1999
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
Waldenström macroglobulinemia
stage II multiple myeloma
stage III multiple myeloma
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Anemia
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014