Venous thromboembolism in patients with multiple myeloma receiving daratumumab-based regimens: a post hoc analysis of phase 3 clinical trials

Leuk Lymphoma. 2021 Sep;62(9):2219-2226. doi: 10.1080/10428194.2021.1910687. Epub 2021 Apr 9.


It is unknown if daratumumab could affect venous thromboembolism (VTE) risks in patients with multiple myeloma (MM). In this study, individual participant data from three trials comparing daratumumab (DARA) and non-DARA regimens, the CASTOR, PULLOX and MAIA trial, were pooled into two groups. A total of 896 and 899 patients received DARA and non-DARA regimens, respectively. After a median follow-up of 13.9 and 13.5 months, there was no significant difference in VTE incidence between the two groups (hazard ratio 0.80, 95% confidence interval 0.57-1.13, p = 0.17). The two groups shared similar VTE risk factors. The SAVED score and IMPEDE-VTE score are two validated VTE risk-stratification tools in MM. In the DARA group, the SAVED score had better performance than the IMPEDE-VTE score in identifying high risk patients.

Keywords: Daratumumab; deep vein thrombosis; multiple myeloma; pulmonary embolism; venous thromboembolism.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal / adverse effects
  • Humans
  • Multiple Myeloma* / complications
  • Multiple Myeloma* / drug therapy
  • Risk Factors
  • Venous Thromboembolism* / chemically induced
  • Venous Thromboembolism* / diagnosis
  • Venous Thromboembolism* / epidemiology


  • Antibodies, Monoclonal
  • daratumumab