Journal of thrombosis and haemostasis : JTH · 2025
Thromboembolism in transplant-ineligible multiple myeloma patients on triplet/quadruplet therapy: a post hoc analysis of BENEFIT trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Chalayer Emilie, Frere Corinne, Daguenet Elisabeth, Lecompte Thomas, Tardy Bernard, Bounouara Ilhame, Sapet Manon, Bobin Arthur, Harel Stephanie, Decaux Olivier, Belhadj Karim, Touzeau Cyrille, Macro Margaret, Mohty Mohamad, Moreau Philippe, Corre Jill, Avet-Loiseau Hervé, Karlin Lionel, Facon Thierry, Perrot Aurore, Hulin Cyrille, Manier Salomon, Frenzel Laurent, Leleu Xavier
Аннотация
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.
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.