Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003341
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
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
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 100-120 gdL are randomized to 1 of 2 treatment arms Patients with hemoglobin levels greater than 120 gdL are not randomized until their hemoglobin levels decrease to 120 gdL 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 90 gdL receive epoetin alfa subcutaneously each week Patients whose hemoglobin levels are at least 90 gdL 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
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 100-120 gdL are randomized to 1 of 2 treatment arms Patients with hemoglobin levels greater than 120 gdL are not randomized until their hemoglobin levels decrease to 120 gdL 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 90 gdL receive epoetin alfa subcutaneously each week Patients whose hemoglobin levels are at least 90 gdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G98-1436 | None | None | None |
| MSKCC-97125 | None | None | None |
| ORTHO-PR-96-27-031 | None | None | None |
| RPCI-DS-97-38 | None | None | None |