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
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 g/dL). 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 g/dL and then randomized to receive 1) Immediate epoetin alfa
treatment or 2) Observed after Hb levels fell below 11 g/dL. Epoetin alfa treatment was
provided to the Observed group if and when Hb levels fell below 9.0 g/dL. 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 g/dL, the patient was randomized to the Immediate or
to the Observed groups. Patients presenting with Hgb > 12 g/dL but otherwise eligible, were
not randomized until Hb dropped to <=12 g/dL. 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 (e.g., blood pressure), and the occurrence and
severity of adverse events. The starting dose of PROCRIT (Epoetin alfa) was administered
subcutaneously (sc) as 40,000 Units (U) once weekly (qw). If after 3-4 weeks of therapy,
the Hb did not increase by > 1.0 g/dL, the dose was increased to 60,000 U sc qw. If at any
time, the Hb rose above 15 g/dL on 2 consecutive evaluations, PROCRIT (Epoetin alfa) was
stopped until the Hb dropped to below 13 g/dL and then resumed.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To measure the change in quality of life score as demonstrated by the FACT-An (Functional Assessment in Cancer Therapy - Anemia) and LASA (Linear Analogue Assessment Scale) tools over the 36 week study period.
Ortho Biotech, Inc. Clinical Trial
Study Director
Ortho Biotech, Inc.
United States: Institutional Review Board
CR005125
NCT00524407
July 1996
November 2002
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