Aspirin, warfarin, or enoxaparin thromboprophylaxis in patients with multiple myeloma treated with thalidomide: A phase III, open-label, randomized trial

Journal of Clinical Oncology

Volumn 29, Issue 8, 2011, Pages 986-993

  Palumbo, Antonio ^a   Cavo, Michele ^a   Bringhen, Sara ^a   Zamagni, Elena ^a   Romano, Alessandra ^a   Patriarca, Francesca ^a   Rossi, Davide ^a   Gentilini, Fabiana ^a   Crippa, Claudia ^a   Galli, Monica ^a   Nozzoli, Chiara ^a   Ria, Roberto ^a   Marasca, Roberto ^a   Montefusco, Vittorio ^a   Baldini, Luca ^a   Elice, Francesca ^a   Callea, Vincenzo ^a   Pulini, Stefano ^a   Carella, Angelo M ^a   Zambello, Renato ^a   Benevolo, Giulia ^a   Magarotto, Valeria ^a   Tacchetti, Paola ^a   Pescosta, Norbert ^a   Cellini, Claudia ^a   Polloni, Claudia ^a   Evangelista, Andrea ^a   Caravita, Tommaso ^a   Morabito, Fortunato ^a   Offidani, Massimo ^a   Tosi, Patrizia ^a   Boccadoro, Mario ^a   more..

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ENOXAPARIN; THALIDOMIDE; WARFARIN;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTERY THROMBOSIS; ARTICLE; CARDIOVASCULAR SYMPTOM; COMPARATIVE EFFECTIVENESS; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE MYELOMA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RISK ASSESSMENT; SUDDEN DEATH; TREATMENT OUTCOME;

EID: 79952752535     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.31.6844     Document Type: Article

References (38)

1. Sallah S, Wan JY, Nguyen NP: Venous thrombosis in patients with solid tumors: Determination of frequency and characteristics. Thromb Haemost 87:575-579, 2002 (Pubitemid 34302943)
2. Walsh-McMonagle D, Green D: Low-molecular- weight heparin in the management of Trousseau's syndrome. Cancer 80:649-655, 1997 (Pubitemid 27339818)
3. Blom JW, Doggen CJ, Osanto S, et al: Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA 293:715-722, 2005 (Pubitemid 40216041)
4. Bick RL: Cancer-associated thrombosis. N Engl J Med 349:109-111, 2003
5. Palumbo A, Bringhen S, Caravita T, et al: Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: Randomised controlled trial. Lancet 367:825-831, 2006 (Pubitemid 43363369)
6. Facon T, Mary JY, Hulin C, et al: Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): A randomised trial. Lancet 370:1209-1218, 2007 (Pubitemid 47516593)
7. Hulin C, Facon T, Rodon P, et al: Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial. J Clin Oncol 27:3664-3670, 2009
8. Musallam KM, Dahdaleh FS, Shamseddine AI, et al: Incidence and prophylaxis of venous thromboembolic events in multiple myeloma patients receiving immunomodulatory therapy. Thromb Res 123:679-686, 2009
9. El Accaoui RN, Shamseddeen WA, Taher AT: Thalidomide and thrombosis: A meta-analysis. Thromb Haemost 97:1031-1036, 2007
10. Hicks LK, Haynes AE, Reece DE, et al: A meta-analysis and systematic review of thalidomide for patients with previously untreated multiple myeloma. Cancer Treat Rev 34:442-452, 2008
11. Cavo M, Zamagni E, Tosi P, et al: Superiority of thalidomide and dexamethasone over vincristine-doxorubicin- dexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma. Blood 106:35-39, 2005 (Pubitemid 40967171)
12. Weber D, Rankin K, Gavino M, et al: Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol 21:16-19, 2003
13. Zangari M, Barlogie B, Anaissie E, et al: Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: Effects of prophylactic and therapeutic anticoagulation. Br J Haematol 126:715-721, 2004 (Pubitemid 39221309)
14. Baz R, Li L, Kottke-Marchant K, et al: The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma. Mayo Clin Proc 80:1568-1574, 2005 (Pubitemid 41747058)
15. Lyman GH, Khorana AA, Falanga A, et al: American Society of Clinical Oncology guideline: Recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol 25:5490-5505, 2007 (Pubitemid 350232226)
16. Cavo M, Tacchetti P, Patriarca F, et al: Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: A randomised phase 3 study. Lancet 376:2075-2085, 2010
17. Palumbo A, Bringhen S, Rossi D, et al: Bortezomib-melphalan-prednisone- thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: A randomised controlled trial. J Clin Oncol 28:5101-5109, 2010
18. Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis: Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 3:692-694, 2005
19. Proschan MA, Waclawiw MA: Practical guidelines for multiplicity adjustment in clinical trials. Control Clin Trials 21:527-539, 2000 (Pubitemid 32056216)
20. Gooley TA, Leisenring W, Crowley J, et al: Estimation of failure probabilities in the presence of competing risks: New representations of old estimators. Stat Med 18:695-706, 1999 (Pubitemid 29126745)
21. Gray RJ: A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 16:1141-1154, 1988
22. Fine P, Gray R: A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 94:496-506, 1999
23. Palumbo A, Rajkumar SV, Dimopoulos MA, et al: Prevention of thalidomide- and lenalidomide-associated thrombosis in myeloma. Leukemia 22: 414-423, 2008 (Pubitemid 351255436)
24. Cavo M, Zamagni E, Cellini C, et al: Deep-vein thrombosis in patients with multiple myeloma receiving first-line thalidomide-dexamethasone therapy. Blood 100:2272-2273, 2002 (Pubitemid 35001274)
25. Miller KC, Padmanabhan S, Dimicelli L, et al: Prospective evaluation of low-dose warfarin for prevention of thalidomide associated venous thromboembolism. Leuk Lymphoma 47:2339-2343, 2006 (Pubitemid 44768427)
26. Ludwig H, Hajek R, Tóthová E, et al: Thalidomide- dexamethasone compared with melphalanprednisolone in elderly patients with multiple myeloma. Blood 113:3435-3442, 2009
27. Harousseau JL, Attal M, Avet-Loiseau H, et al: Bortezomib plus dexamethasone is superior to vincristine plus doxorubicin plus dexamethasone as induction treatment prior to autologous stem-cell transplantation in newly diagnosed multiple myeloma: Results of the IFM 2005-01 phase III trial. J Clin Oncol 28:4621-4629, 2010
28. Jagannath S, Durie BG, Wolf JL, et al: Extended follow-up of a phase 2 trial of bortezomib alone and in combination with dexamethasone for the frontline treatment of multiple myeloma. Br J Haematol 146:619-626, 2009
29. Richardson PG, Xie W, Mitsiades C, et al: Single-agent bortezomib in previously untreated multiple myeloma: Efficacy, characterization of peripheral neuropathy and molecular correlation with response and neuropathy. J Clin Oncol 27:3518-3525, 2009
30. Zangari M, Guerrero J, Cavallo F, et al: Hemostatic effects of bortezomib treatment in patients with relapsed or refractory multiple myeloma. Haematologica 93:953-954, 2008 (Pubitemid 351821742)
31. Palumbo A, Falco P, Corradini P, et al: Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: A report from the GIMEMA-Italian Multiple Myeloma Network. J Clin Oncol 25:4459-4465, 2007 (Pubitemid 350063804)
32. Palumbo A, Dimopoulos MA, Delforge M, et al: A phase III study to determine the efficacy and safety of lenalidomide in combination with melphalan and prednisone (MPR) in elderly patients with newly diagnosed multiple myeloma. Blood 114:253, 2009 (abstr 613)
33. Richardson PG, Weller E, Lonial S, et al: Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma. Blood 116:679-686, 2010
34. Agnelli G, Gussoni G, Bianchini C, et al: Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: A randomised, placebo-controlled, double-blind study. Lancet Oncol 10:943-949, 2009
35. Levine M, Hirsh J, Gent M, et al: Double-blind randomised trial of a very-low-dose warfarin for prevention of thromboembolism in stage IV breast cancer. Lancet 343:886-889, 1994 (Pubitemid 24113632)
36. Kuenen BC: Analysis of prothrombotic mechanisms and endothelial perturbation during treatment with angiogenesis inhibitors. Pathophysiol Haemost Thromb 33:13-14, 2002 (suppl 1)
37. Echart C, Disasto M, Ferro L, et al: Defibrotide induces downregulation of heparenase expression in multiple myeloma cell lines: A novel mechanism of action. Haematologica 92:146, 2007 (suppl 2)
38. Palumbo A, Larocca A, Genuardi M, et al: Melphalan, prednisone, thalidomide and defibrotide in relapsed/refractory multiple myeloma: Results of a multicenter phase I/II trial. Haematologica 95: 1144-1149, 2010