Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524407
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2007-08-30
Brief Title:
Effect of Epoetin Alfa on Hemoglobin Symptom Distress and Quality of Life in Patients Receiving Chemotherapy
Sponsor:
Ortho Biotech Inc
Organization:
Ortho Biotech Clinical Affairs LLC
Study Overview
Official Title:
The Effects of PROCRIT Epoetin Alfa on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Chronic Lymphocytic Leukemia or Multiple Myeloma Patients With Mild to Moderate Anemia
Status:
COMPLETED
Status Verified Date:
2010-04
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:
The purpose of this study was to compare the effectiveness of epoetin alfa treatment on hemoglobin Hb response quality of life QoL health care resource utilization and patient productivity when epoetin alfa was administered during chemotherapy to patients with mild anemia or after waiting until patients became moderately anemic Patients with lymphoma chronic lymphocytic leukemia CLL or Multiple Myeloma MM were studied
Detailed Description:
This study was an open-label patients and investigators knew what treatment was being given randomized patients were assigned to a treatment group by chance study of lymphoma chronic lymphocytic leukemia CLL or multiple myeloma patients This study addressed the clinical and patient-management consequences of treating mild to moderate anemia hemoglobin Hb between 10 and 12 gdL The design of the study compared the effect of treating higher Hb levels to current standard of care criteria on Hb levels transfusion requirements and patient reported outcomes quality of life health care resource utilization and productivity Patients were randomized according to their Hb levels Two entry criteria were specified during the course of the trial Initially patients were enrolled with Hb levels 11 gdL and then randomized to receive 1 Immediate epoetin alfa treatment or 2 Observed after Hb levels fell below 11 gdL Epoetin alfa treatment was provided to the Observed group if and when Hb levels fell below 90 gdL Slow recruitment of patients in to the study resulted in a protocol amendment Subsequently if a patient presented with a Hb between 10 and 12 gdL the patient was randomized to the Immediate or to the Observed groups Patients presenting with Hgb 12 gdL but otherwise eligible were not randomized until Hb dropped to 12 gdL Patients remained in the study for up to 36 weeks Safety assessments were performed throughout the study and included obtaining and evaluating laboratory tests vital signs eg blood pressure and the occurrence and severity of adverse events The starting dose of PROCRIT Epoetin alfa was administered subcutaneously sc as 40000 Units U once weekly qw If after 3-4 weeks of therapy the Hb did not increase by 10 gdL the dose was increased to 60000 U sc qw If at any time the Hb rose above 15 gdL on 2 consecutive evaluations PROCRIT Epoetin alfa was stopped until the Hb dropped to below 13 gdL and then resumed
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