The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
391
Q3W 300 mcg darbepoetin alfa
Q3W dosing of placebo
Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
Time frame: from week 5 to EOTP
Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP
Time frame: from week 5 to EOTP
Number of RBC transfusions from week 5 to EOTP
Time frame: from week 5 to EOTP
Change in FACT-Fatigue subscale score from baseline to EOTP
Time frame: from baseline to EOTP
Change in FACT-G Physical Well-being subscale from baseline to EOTP
Time frame: from baseline to EOTP
Incidence and severity of adverse events
Time frame: throughout study
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
Time frame: at any time on study
Change in FACT-G total score from baseline to EOTP
Time frame: from baseline to EOTP
Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences
Time frame: throughout study
Change in EQ-5D Thermometer from baseline to EOTP
Time frame: from baseline to EOTP
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in BSI Anxiety scale score from baseline to EOTP
Time frame: from baseline to EOTP
Change in BSI Depression scale score from baseline to EOTP
Time frame: from baseline to EOTP
Change in number of caregiver hours from baseline to EOTP
Time frame: from baseline to EOTP
Incidence of a confirmed antibody formation to darbepoetin alfa
Time frame: throughout study