Intravenous immunoglobulin and CMV-seronegative blood products for prevention of CMV infection and disease in bone marrow transplant recipients.

The efficacy of i.v. immunoglobulin plus CMV-seronegative blood products or CMV-seronegative blood products alone for prevention of CMV infection, symptomatic CMV disease, other infections and GVHD after BMT was evaluated in a randomized, controlled trial. Fifty-one CMV-seronegative allogeneic BMTs with a CMV-seronegative or CMV-seropositive marrow donor were randomly assigned to receive either i.v. immunoglobulin (1.0 g/kg once weekly for 120 days after transplant) plus CMV-seronegative blood products or CMV-seronegative blood products alone. CMV infection occurred in 2 of 25 patients (7%) receiving i.v. immunoglobulin plus CMV-seronegative blood and in 2 of 23 patients (9%) receiving CMV-seronegative blood alone. All CMV infections were asymptomatic and characterized by viral excretion with or without CMV seroconversion. There were no cases of CMV-related interstitial pneumonia. Grade > or = II GVHD was less frequent in patients given i.v. immunoglobulin (5 of 25 patients (20%) vs. 11 of 23 patients (48%), p = 0.04). The number of bacterial and fungal infections was similar in both groups. Fewer non-CMV viral infections (9 of 27 patients (33%) vs. 15 of 24 patients (63%), p = 0.03) and fewer deaths associated with infection (1 of 27 patients (4%) vs. 5 of 24 patients (21%), p = 0.07) occurred in recipients of immunoglobulin. Neither survival nor risk of leukemia relapse was changed by the immunoglobulin. The high doses of i.v. immunoglobulin were well tolerated. These results suggest that CMV-seronegative blood products alone prevent most CMV infections and CMV disease in CMV-seronegative allogeneic BMT recipients, even when the marrow donor is CMV-seropositive.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes