TY - JOUR
T1 - Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide
AU - Larocca, Alessandra
AU - Cavallo, Federica
AU - Bringhen, Sara
AU - Di Raimondo, Francesco
AU - Falanga, Anna
AU - Evangelista, Andrea
AU - Cavalli, Maide
AU - Stanevsky, Anfisa
AU - Corradini, Paolo
AU - Pezzatti, Sara
AU - Patriarca, Francesca
AU - Cavo, Michele
AU - Peccatori, Jacopo
AU - Catalano, Lucio
AU - Carella, Angelo Michele
AU - Cafro, Anna Maria
AU - Siniscalchi, Agostina
AU - Crippa, Claudia
AU - Petrucci, Maria Teresa
AU - Yehuda, Dina Ben
AU - Beggiato, Eloise
AU - Di Toritto, Tommaso Caravita
AU - Boccadoro, Mario
AU - Nagler, Arnon
AU - Palumbo, Antonio
N1 - Funding Information:
1This research is supported in part by an Intel Ph.D. Research Fellowship, by Microsoft (Award #024263), by Intel (Award #024894), and by matching fund from U.C. Discovery (Award #DIG07-10227).
PY - 2012/1/26
Y1 - 2012/1/26
N2 - 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 patients with newly diagnosed MM, treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation. Overall, 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were randomly assigned to receive ASA 100 mg/d (n = 176) or LMWH enoxaparin 40 mg/d (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% confidence interval, -1.69-3.83; P = .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 patients with MM receiving lenalidomide with a low thromboembolic risk, ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis. This study was registered at www.clinicaltrials.gov as #NCT00551928.
AB - 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 patients with newly diagnosed MM, treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation. Overall, 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were randomly assigned to receive ASA 100 mg/d (n = 176) or LMWH enoxaparin 40 mg/d (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% confidence interval, -1.69-3.83; P = .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 patients with MM receiving lenalidomide with a low thromboembolic risk, ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis. This study was registered at www.clinicaltrials.gov as #NCT00551928.
UR - http://www.scopus.com/inward/record.url?scp=84055161444&partnerID=8YFLogxK
U2 - 10.1182/blood-2011-03-344333
DO - 10.1182/blood-2011-03-344333
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C2 - 21835953
AN - SCOPUS:84055161444
SN - 0006-4971
VL - 119
SP - 933
EP - 939
JO - Blood
JF - Blood
IS - 4
ER -
