Full Text View
Tabular View
No Study Results Posted
Related Studies
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
This study is ongoing, but not recruiting participants.
Study NCT00003341   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: August 19, 2009   History of Changes

November 1, 1999
August 19, 2009
December 1997
 
 
 
Complete list of historical versions of study NCT00003341 on ClinicalTrials.gov Archive Site
 
 
 
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
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

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.

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.

Phase III
Interventional
Supportive Care, Randomized, Open Label, Active Control
  • Anemia
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Biological: epoetin alfa
  • Procedure: quality-of-life assessment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
275
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003341
 
CDR0000066316, MSKCC-97125, ORTHO-PR-96-27-031, RPCI-DS-97-38, NCI-G98-1436
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David J. Straus, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP