title: Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide.
abstract: 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.
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) S. Giovanni Battista, Torino, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Larocca
authors.forename: Federica
authors.initials: F
authors.lastname: Cavallo
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Anna
authors.initials: A
authors.lastname: Falanga
authors.forename: Andrea
authors.initials: A
authors.lastname: Evangelista
authors.forename: Maide
authors.initials: M
authors.lastname: Cavalli
authors.forename: Anfisa
authors.initials: A
authors.lastname: Stanevsky
authors.forename: Paolo
authors.initials: P
authors.lastname: Corradini
authors.forename: Sara
authors.initials: S
authors.lastname: Pezzatti
authors.forename: Francesca
authors.initials: F
authors.lastname: Patriarca
authors.forename: Michele
authors.initials: M
authors.lastname: Cavo
authors.forename: Jacopo
authors.initials: J
authors.lastname: Peccatori
authors.forename: Lucio
authors.initials: L
authors.lastname: Catalano
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Cafro
authors.forename: Agostina
authors.initials: A
authors.lastname: Siniscalchi
authors.forename: Claudia
authors.initials: C
authors.lastname: Crippa
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Dina Ben
authors.initials: DB
authors.lastname: Yehuda
authors.forename: Eloise
authors.initials: E
authors.lastname: Beggiato
authors.forename: Tommaso Caravita
authors.initials: TC
authors.lastname: Di Toritto
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
authors.forename: Arnon
authors.initials: A
authors.lastname: Nagler
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D007557:Israel / Q000453:epidemiology; D007558:Italy / Q000453:epidemiology; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011655:Pulmonary Embolism / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control; D012307:Risk Factors; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D054556:Venous Thromboembolism / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D000970:Antineoplastic Agents; D017984:Enoxaparin; D010975:Platelet Aggregation Inhibitors; D013792:Thalidomide; D000077269:Lenalidomide; D001241:Aspirin