A predictive model for risk of early grade\u2009 65\u20093 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial

Infections are a major cause of death in patients with multiple myeloma. A post hoc analysis of the phase 3 FIRST trial was conducted to characterize treatment-emergent (TE) infections and study risk factors for TE grade\u2009 65\u20093 infection. The number of TE infections/month was highest during the first 4 months of treatment (defined as early infection). Of 1613 treated patients, 340 (21.1%) experienced TE grade\u2009 65\u20093 infections in the first 18 months and 56.2% of these patients experienced their first grade\u2009 65\u20093 infection in the first 4 months. Risk of early infection was similar regardless of treatment. Based on the analyses of data in 1378 patients through multivariate logistic regression, a predictive model of first TE grade\u2009 65\u20093 infection in the first 4 months retained Eastern Cooperative Oncology Group performance status and serum \u3b22-microglobulin, lactate dehydrogenase, and hemoglobin levels to define high- and low-risk groups showing significantly different rates of infection (24.0% vs. 7.0%, respectively; P\u2009<\u20090.0001). The predictive model was validated with data from three clinical trials. This predictive model of early TE grade\u2009 65\u20093 infection may be applied in the clinical setting to guide infection monitoring and strategies for infection prevention