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Aspirin or enoxaparin thromboprophylaxis for newly-diagnosed multiple myeloma patients treated with lenalidomide.

Author(s): Larocca A, Cavallo F, Bringhen S, Di Raimondo F, Falanga A, Evangelista A, Cavalli M, Stanevsky A, Corradini P, Pezzati S, Patriarca F, Cavo M, Peccatori J, Catalano L, Carella AM, Cafro AM, Siniscalchi A, Crippa C, Petrucci MT, Ben Yehuda D, Beggiato E, Caravita Di Toritto T, Boccadoro M, Nagler A, Palumbo A

Affiliation(s): Myeloma Unit, Division of Hematology, University of Torino, AOU S Giovanni Battista, Torino, Italy;

Publication date & source: 2011-08-11, Blood., [Epub ahead of print]

Lenalidomide plus dexamethasone is effective in the treatment of multiple myeloma (MM) but is associated with an increased risk of venous thromboembolism (VTE). This prospective, open-label, randomized substudy of a phase 3 trial compared the efficacy and safety of thromboprophylaxis with low-dose aspirin (ASA) or low-molecular-weight heparin (LMWH) in newly-diagnosed MM patients, treated with lenalidomide and low-dose dexamethasone (Rd) induction and melphalan-prednisone-lenalidomide consolidation. Overall, 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy, were randomized to receive ASA 100 mg/day (n=176) or LMWH enoxaparin 40 mg/day (n=166). The incidence of VTE was 2.27% in the ASA group and 1.20% in the LMWH group. Compared with LMWH, the absolute difference in the proportion of VTE was +1.07% (95% CI, -1.69 to 3.83; P = 0.452) in the ASA group. Pulmonary embolism was observed in 1.70% of patients in the ASA group and none in the LMWH group. No arterial thrombosis, acute cardiovascular events, or sudden deaths were reported. No major hemorrhagic complications were reported. In previously untreated MM patients receiving lenalidomide with a low thromboembolic risk, ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis. This study is registered at http://www.clinicaltrials.gov as NCT00551928.

Page last updated: 2011-12-09

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