RANDOMIZED TRIAL OF INTRAVENOUS IMMUNOGLOBULIN AS PROPHYLAXIS AGAINSTINFECTION IN PLATEAU-PHASE MULTIPLE-MYELOMA

Patients with plateau-phase multiple myeloma have an increased risk of life-threatening bacterial infections and polyclonal humoral immune s uppression. We conducted a randomised, double-blind, placebo-controlle d, multicentre trial of intravenous immunoglobulin (IVIg) as prophylax is against infection. 82 patients with stable multiple myeloma receive d monthly infusions of IVIg at 0.4 g/kg body weight or an equivalent v olume of placebo (0.4% albumin) intravenously for 1 year. Other interv entions, including chemotherapy, were not affected; no patient receive d prophylactic antibiotics. There were no differences at entry or on s tudy in clinical or laboratory variables between patients in the two g roups. There were no episodes of septicaemia or pneumonia in patients receiving IVIg compared with 10 in placebo patients (p=0.002). There w ere 57 serious infections; 38 occurred in 470 patient-months on placeb o, compared with 19 in 449 patient-months on IVIg (p=0.019). IVIg also protected against recurrent infections (p=0.021) in 60 patients who c ompleted a year. Before treatment, 54 patients were immunised with Pne umovax and specific IgG responses were measured. A poor pneumococcal I gG antibody response (less than 2-fold increase) identified patients w ho had maximum benefit from IVIg. Mild adverse reactions were noted in 12% of IVIg infusions and 5% of placebo infusions. IVIg can be given safely to plateau-phase myeloma patients. It protects against life-thr eatening infections and significantly reduces the risk of recurrent in fections. The individuals who benefit most can be identified prospecti vely by measuring IgG antibody responses to pneumococcal immunisation.