Development and validation of a new risk assessment model for immunomodulatory drug- associated venous thrombosis among Chinese patients with multiple myeloma

Abstract

Abstract Background Venous thromboembolism (VTE) is a serious complication that can occur in individuals with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs). There is no available standard clinical model for predicting VTE in the Chinese population. We develop a new risk assessment model (RAM) for IMiD-associated VTE in Chinese MM patients. Methods We retrospectively selected 1334 consecutive MM patients receiving IMiDs from 16 medical centres in China and classified them randomly into the derivation cohort and the validation cohort. A multivariate Cox regression model was used for analysis. Results The overall incidence of IMiD-related VTE in Chinese MM patients was 6.1%. Independent predictive factors of VTE (diabetes, ECOG performance status, erythropoietin-stimulating agent use, dexamethasone use, and VTE history or family history of thrombosis) were identified and merged to develop the RAM. The model identified approximately 30% of the patients in each cohort as being at high risk for VTE. The hazard ratios (HRs) were 6.08 (P < 0.001) and 6.23 (P < 0.001) for the high-risk subcohort and the low-risk subcohort, respectively, within both the derivation and validation cohorts. The stratification approach of the IMWG guidelines yielded respective HRs of 1.77 (P = 0.053) and 1.81 (P = 0.063). The RAM achieved satisfactory discrimination with a C statistic of 0.64. The IMWG guideline-based method yielded a C statistic of 0.58. Conclusions The new RAM outperformed the IMWG guidelines and has the potential to guide the VTE prophylaxis strategy for Chinese MM patients.