Effects of epoetin alfa on transfusions, haemoglobin (Hb) and quality of life (QOL) were evaluated in a placebo-controlled study of 145 patients with multiple myeloma and anaemia (Hb < 11 g/dl). During the 12-week, double-blind phase, patients received 150 IU/kg epoetin alfa or a matching volume of placebo subcutaneously three times weekly; the dose (or volume) was doubled at week 4 if Hb response was inadequate. Patients completing this phase could enter the subsequent optional 12-week phase of open-label epoetin alfa treatment. During double-blind treatment, epoetin alfa significantly decreased the incidence of transfusion compared with placebo (28% vs. 47%, P = 0.017), regardless of patients' transfusion history, and increased mean Hb (1.8 g/dl vs. 0.0 g/dl, P < 0.001). Univariate analysis showed significant (P </= 0.05) improvement in more QOL measures with epoetin alfa than with placebo; multivariate analysis discerned no between-treatment differences. Significantly (P = 0.038) more epoetin alfa vs. placebo patients had improved performance scores. At the end of the open-label treatment phase, patients who had continued epoetin alfa maintained Hb status, and placebo patients who were switched to epoetin alfa had mean Hb increases of 2.4 g/dl. Adverse events were similar between treatment groups. Epoetin alfa proved effective and well tolerated for treating anaemia in patients with multiple myeloma.