A predictive model for risk of early grade ≥ 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial

Infectionsare a major cause of death in patients with multiple myeloma. A post hoc analysisof the phase 3 FIRST trial was conducted to characterize treatment-emergent (TE) infectionsand study risk factors for TE grade ≥ 3 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 ≥ 3 infectionsin the first 18 months and 56.2% of these patients experienced their first grade ≥ 3 infectionin the first 4 months. Risk of early infectionwas similar regardless of treatment. Based on the analyses of data in 1378 patients through multivariate logistic regression, a predictive modelof first TE grade ≥ 3 infectionin the first 4 months retained Eastern Cooperative Oncology Group performance statusand serum β2-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 < 0.0001). The predictive modelwas validated with data from three clinical trials. This predictive modelof early TE grade ≥ 3 infectionmay be applied in the clinical setting to guide infectionmonitoring and strategies for infectionprevention.