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Dr. Palumbo - A Prospective, Randomized, Phase III Study of Enoxaparin Versus Aspirin Versus Low-Fixed-Dose of Warfarin in Newly Diagnosed Myeloma Patients Treated with Thalidomide-Containing Regimens
Antonio Palumbo, MD
Ospedale Molinette
Torino, Italy
Member,IMF Board of Scientific Advisors
12.21.07

"The implication of this study is at the end of the day, you can use whatever anticoagulant prophylaxis you prefer, but if the patient has particular risk of DVT, you may prefer low molecular weight Heparin."
Dr. Antonio Palumbo


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[310] A Prospective, Randomized, Phase III Study of Enoxaparin Versus Aspirin Versus Low-Fixed-Dose of Warfarin in Newly Diagnosed Myeloma Patients Treated with Thalidomide-Containing Regimens. Session Type: Oral Session

Antonio Palumbo, Michele Cavo, Sara Bringhen, Giulia Perrone, Valeria Magarotto, Francesca Patriarca, Maria Teresa Petrucci, Monica Galli, Francesco Di Raimondo, Davide Rossi, Roberto Marasca, Massimo Offidani, Maria Goldaniga, Paolo Corradini, Claudia Crippa, Lucio Catalano, Vincenzo Callea, Antonella Gozzini, Patrizia Tosi, Mario Boccadoro Divisione di Ematologia dellUniversit di Torino, Az. Osp. San Giovanni Battista, Torino, Italy; Istituto di Ematologia e Oncologia Medica Sergnoli, Universit di Bologna, Bologna, Italy; Italian Multiple Myeloma Network, GIMEMA, Italy; First Authorship Equally Shared

Background: The risk of venous thromboembolism (VTE) is high in newly diagnosed myeloma (MM) patients who receive thalidomide-containing regimens. Anticoagulant prophylaxis is recommended but its not clear which is more appropriate. In this prospective, multicenter phase III trial we evaluated the safety and the efficacy of low-molecular weight heparin (LMWH) or low-dose aspirin (ASA) or low-fixed dose warfarin (WAR) as anticoagulant prophylaxis. Methods: In a GIMEMA study, newly diagnosed MM patients were randomized to VTD (Velcade 1.3 mg/m d 1,4,8,11; Thalidomide 200 mg/d; high-dose Dexamethasone 320 mg/21 d) or TD (Thalidomide 200 mg/d; high-dose Dexamethasone 320 mg/21 d) or VMPT (Velcade 1.3 mg/m d 1,8,15,22; Melphalan 9 mg/m d 1-4; Prednisone 60 mg/m d 1-4; Talidomide 50 mg/d) or VMP (Velcade 1.3 mg/m d 1,8,15,22; Melphalan 9 mg/m d 1-4; Prednisone 60 mg/m d 1-4). In a sub-study, patients treated with VTD or TD or VMPT were randomly assigned to receive LMWH (Enoxaparin 40 mg/d) or ASA (Aspirin 100 mg/d) or WAR (Warfarin 1.25 mg/d) for the duration of the induction therapy. Patients treated with VMP did not receive any prophylaxis and were used as controls. End-points were incidence of VTE, acute cardiovascular events, sudden death, bleeding and any other serious adverse events. A total of 950 patients will be included in this study. An interim analysis was performed after the first 200 patients were enrolled. Results: Eighty-two patients received VTD, 84 TD, 34 VMPT and 35 VMP. Two-hundred patients (117 males, median age 58 years) were analyzed: 65 patients were randomized to LMWH, 66 to ASA and 69 to WAR. Patient characteristics were similar in all groups. All patients completed at least the first 3 cycles of therapy. The incidence of VTE was 2/65 (3%) in the LMWH group, 6/66 (9%) in the ASA group and 2/69 (3%) in the WAR group, but differences did not reach statistical significance. VTEs were 2/35 (6%) in the VMP group who did not received any prophylaxis. The cumulative incidence of VTE was 4/116 (3%) in patients treated with Velcade plus Thalidomide, and 6/84 (7%) in those treated with TD (p=0.33). No acute cardiovascular events or sudden deaths were reported. The incidence of bleeding was 0/65 (0%) in the LMWH group, 2/66 (3%) in the ASA group and 2/69 (3%) in the WAR group. Conclusion: The overall incidence of VTE was less than 10% in all groups. ASA patients had higher frequency of VTE; LMWH patients had lower risk of bleeding; patients who received Velcade had lower frequency of VTE. An update of these data and an analysis of risk factors will be presented at the meeting.

Abstract #310 appears in Blood, Volume 110, issue 11, November 16, 2007

Keywords: Multiple Myeloma|Thalidomide|Antithrombotic Therapy

Disclosure: No relevant conflicts of interest to declare.

Monday, December 10, 2007 11:45 AM

Session Info: Simultaneous Session: Antithrombotic Therapy: New Anticoagulants (11:00 a.m.-12:30 p.m.)


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