Thromboembolism in transplant-ineligible multiple myeloma patients on triplet/quadruplet therapy: a post hoc analysis of BENEFIT trial.

BACKGROUND

Venous thromboembolism (VTE) events remain a major concern for patients with newly diagnosed multiple myeloma (nMM) undergoing therapy.

OBJECTIVES

Evaluate the incidence and risk factors for VTE.

METHODS

Post hoc analysis of the randomized phase 3 BENEFIT trial (NCT04751877) evaluating 257 patients aged 65 to 79 years with transplant-ineligible nMM who received isatuximab/bortezomib/lenalidomide/dexamethasone or isatuximab/lenalidomide/dexamethasone.

RESULTS

In the whole cohort, the 6-month cumulative incidence of VTE was 4.8% (95% CI, 2.7%-8.1%), 0.8% (95% CI, 0.1%-5.6%) in patients receiving low-dose direct oral anticoagulants (DOACs) compared with 5.6% (95% CI, 1.9%-16.7%) in those who received prophylactic-dose heparin, and 9.8% (95% CI, 3.9%-24.75%) in patients receiving aspirin. Only 1 VTE occurred beyond the 6-month period. The most frequently used thromboprophylaxis agents were DOACs (n = 127, 55.2%), low-molecular-weight heparins (n = 54, 23.5%), and aspirin (n = 40, 17.4%). We noted that one-third of patients who experienced VTE had not received thromboprophylaxis. Among the different thromboprophylaxis regimens used, only low-dose DOAC was associated with a significant reduction in the risk of VTE. In multivariate analysis, proteinuria ≥ 0.44 g/L (hazard ratio [HR], 5.8; 95% CI, 1.7-26.8) and monoclonal protein concentration ≥ 22 g/L (HR, 4.9; 95% CI, 1.3-31.9) were significantly associated with an increased risk of VTE, while low-dose DOAC was associated with a decreased risk of VTE (HR, 0.13; 95% CI, 0.007-0.67).

CONCLUSION

In summary, the cumulative incidence of VTE remains high in patients with transplant-ineligible nMM. DOACs could be the most effective option for preventing VTE.