Clinical trial NCT00003341: Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Keywords: 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
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
anemia
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-25
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Centers of the Desert
state: California
city: Palo Alto
country: United States
facility: Division of Oncology
state: California
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Chicago
country: United States
facility: Rush Cancer Institute
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Baltimore
country: United States
facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David J. Straus, MD
role: STUDY_CHAIR
References: