Blood Journal
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CME article
Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide

  1. Alessandra Larocca1,
  2. Federica Cavallo1,
  3. Sara Bringhen1,
  4. Francesco Di Raimondo2,
  5. Anna Falanga3,
  6. Andrea Evangelista4,
  7. Maide Cavalli2,
  8. Anfisa Stanevsky5,
  9. Paolo Corradini6,
  10. Sara Pezzatti7,
  11. Francesca Patriarca8,
  12. Michele Cavo9,
  13. Jacopo Peccatori10,
  14. Lucio Catalano11,
  15. Angelo Michele Carella12,
  16. Anna Maria Cafro13,
  17. Agostina Siniscalchi14,
  18. Claudia Crippa15,
  19. Maria Teresa Petrucci16,
  20. Dina Ben Yehuda17,
  21. Eloise Beggiato18,
  22. Tommaso Caravita Di Toritto14,
  23. Mario Boccadoro1,
  24. Arnon Nagler5, and
  25. Antonio Palumbo1
  1. 1Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) S. Giovanni Battista, Torino, Italy;
  2. 2Divisione di Ematologia, Ospedale Ferrarotto, Università di Catania, Catania, Italy;
  3. 3Division of Immunohematology and Tranfusion Medicine, Ospedali Riuniti, Bergamo, Italy;
  4. 4Unità di Epidemiologia dei Tumori, AOU San Giovannni Battista e Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in Piemonte, Torino, Italy;
  5. 5Hematology Division and Cord Blood Bank, Chaim Sheba Medical Center, Tel-Hashomer, Israel;
  6. 6Fondazione Instituto di Ricovero e Cura Carattere Scientifico Istituto Nazionale dei Tumori, Università di Milano, Milan, Italy;
  7. 7Centro di Ematologia e Trapianto di Midollo, Azienda Ospedaliera S. Gerardo, Monza, Italy;
  8. 8Clinica Ematologica Dipartimento Scienze Mediche Sperimentali Cliniche, Università di Udine, Udine, Italy;
  9. 9Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy;
  10. 10Myeloma Unit, San Raffaele Scientific Institute, Milan, Italy;
  11. 11Divisione di Ematologia, Università Federico II, Napoli, Italy;
  12. 12Unità Operativa Complessa (UOC) Ematologia 1, Azienda Ospedaliera Universitaria san Martino-Genova, Genova, Italy;
  13. 13Ematologia, Azienda Ospeclaliera Niguarda Ca' Granda, Milan, Italy;
  14. 14Divisione di Ematologia, Ospedale S. Eugenio, Roma, Italy;
  15. 15Divisione di Ematologia Spedali Civili, Brescia, Italy;
  16. 16Hematology, Sapienza University of Roma, Italy;
  17. 17Hadassah Medical Center, Jerusalem, Israel; and
  18. 18Struttura Semplice Con Valenza Dipartimentale Malattie Trombotiche ed Emorragiche dell'adulto, Ospedale Molinette, Torino, Italy

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. This study was registered at www.clinicaltrials.gov as #NCT00551928.

  • Submitted March 23, 2011.
  • Accepted August 4, 2011.
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