Effects of epoetin alfa on transfusions, haemoglobin (Hb) and quality of Li
fe (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-bli
nd 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 co
uld enter the subsequent optional 12-week phase of open-label epoetin alfa
treatment. During double-blind treatment, epoetin alfa significantly decrea
sed 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
less than or equal to 0.05) improvement in more QOL measures with epoetin
alfa than with placebo; multivariate analysis discerned no between-treatmen
t differences. Significantly (P = 0.038) more epoetin alfa vs, placebo pati
ents had improved performance scores. At the end of the open-label treatmen
t 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 al
fa proved effective and well tolerated for treating anaemia in patients wit
h multiple myeloma.