A multicenter, randomized, double-blind comparison of different doses of intravenous immunoglobulin for prevention of graft-versus-host disease and infection after allogeneic bone marrow transplantation

Intravenous immunoglobulin is approved for use in allogeneic bone marrow tr ansplant recipients for prevention of graft-versus-host disease (GVHD) and infections, but the minimally effective dose has not been established. In t his multicenter, randomized, double-blind trial, patients undergoing alloge neic marrow transplantation were randomized to receive 100 mg/kg, 250 mg/kg , or 500 mg/kg doses of intravenous immunoglobulin. Each dose was given wee kly for 90 days and then monthly until 1 year after transplant. Six hundred and eighteen patients were evaluated. Acute GVHD (grades 2-4) occurred in 39% of the patients (80 of 206) in the 100 mg/kg group, 42% of the patients (88 of 208) in the 250 mg/kg group, and in 35% of the patients (72 of 204) in the 500 mg/kg group (P = 0.344). Among patients with unrelated marrow d onors, a higher dose of intravenous immunoglobulin (500 mg/kg) was associat ed with less acute GVHD (P = 0.07). The incidences of chronic GVHD, infecti on and interstitial pneumonia were similar for all three doses of intraveno us immunoglobulin. The dose of intravenous immunoglobulin also had no effec t on the types of infection, relapse of hematological malignancy or surviva l. Except for more frequent chills (P = 0.007) and headaches (P = 0.015) in patients given the 500 mg/kg or 250 mg/kg dose of immunoglobulin, adverse events were similar for all three doses. These results suggest that 100 mg/ kg, 250 mg/kg, and 500 mg/kg doses of intravenous immunoglobulin are associ ated with similar incidences of GVHD and infections in most allogeneic marr ow transplants. These results should be considered when designing cost-effe ctive strategies for the use of intravenous immunoglobulin in allogeneic ma rrow transplants receiving other current regimens for prophylaxis of GVHD a nd infection.