Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double‐blind, placebo‐controlled study

• Published in: British journal of haematology 2003-08, Vol.122 (3), p.394-403
• Main Authors: Hedenus, Michael, Adriansson, Magnus, Miguel, Jesus San, Kramer, Mark H. H., Schipperus, Martin R., Juvonen, Eeva, Taylor, Kerry, Belch, Andrew, Altés, Albert, Martinelli, Giovanni, Watson, David, Matcham, James, Rossi, Gregory, Littlewood, Timothy J.
• Format: Article
• Language: English
• Subjects: Aged; anaemia; Analysis of Variance; Anemia - drug therapy; Anemia - etiology; Antineoplastic agents; Biological and medical sciences; Blood Transfusion; cancer; Chemotherapy; Darbepoetin alfa; Diarrhea - drug therapy; Double-Blind Method; erythropoietin; Erythropoietin - adverse effects; Erythropoietin - analogs & derivatives; Erythropoietin - therapeutic use; Fatigue - drug therapy; Female; Fever - drug therapy; Follow-Up Studies; Hematology; Humans; Linear Models; lymphoma; Lymphoma - complications; Lymphoma - drug therapy; Lymphoproliferative Disorders - complications; Lymphoproliferative Disorders - drug therapy; Male; Medical sciences; Middle Aged; Multiple Myeloma - complications; Multiple Myeloma - drug therapy; myeloma; Nausea - drug therapy; Pharmacology. Drug treatments; Quality of Life
• ISSN: 0007-1048; 1365-2141; 1365-2141
• DOI: 10.1046/j.1365-2141.2003.04448.x

This phase 3, randomized, double‐blind, placebo‐controlled study was designed to evaluate the efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Patients (n = 344) with lymphoma or myeloma received darbepoetin alfa 2·25 μg/kg or placebo s.c., once weekly for 12 weeks. The percentage of patients achieving a haemoglobin response was significantly higher in the darbepoetin alfa group (60%) than in the placebo group (18%) (P