Disclosures
Research Support/P.
none
Employee
none
Consultant
none
Major Stockholder
none
Speakers Bureau
none
Honoraria
Celgene, Janssen-Cilag
Scientific Advisory Board
none
Presentation includes discussion of the off-label use of a drug or drugs
1
ASCO Guidelines
"Prophylaxis with LMWH or WAR is recommended in MM
patients receiving Thalidomide or Lenalidomide with
chemotherapy and/or dexamethasone"
Randomized trials for Lenalidomide are still lacking
2
3
Patient characteristics
ASA
LMWH
N=176
N=166
Age (median)
57
58
60 years
36 %
40 %
MPR
48 %
48 %
Mel 200 mg/m2
52 %
52 %
Cardiac disease
7 %
4 %
Diabetes
1 %
1 %
Inherited conditions
0 %
0 %
Concomitant rHuEpo
17 %
17 %
1 Risk factor
2 %
1 %
4
Results
ASA
LMWH
Absolute
P-value
N=176
N=166
difference,
%
Efficacy analysis, n (%)
Composite primary endpoint
4 (2.27)
2 (1.20)
1.07
0.452
Any grade 3/4
4 (2.27)
2 (1.20)
1.07
0.452
thromboembolic event, n (%)
Deep-vein thrombosis
2 (1.14)
2 (1.20)
-0.07
0.953
Pulmonary embolism
3 (1.70)
0
1.70
0.091
Arterial thrombosis
0
0
-
-
Acute cardiovascular events
0
0
-
-
Sudden deaths
0
0
-
-
VTE characteristics
Prophylaxis
Age
Sex
ISS
KPS
Risk Factors
VTE
Treatment
ASA
57
M
2
70
rHuEpo
PE
Rd
ASA
55
F
3
70
rHuEpo
PE
Rd
ASA
57
F
1
70
rHuEpo
PE
Rd
ASA
61
F
3
90
None
DVT
Rd
LMWH
52
M
1
100
None
DVT
Rd
LMWH
58
F
3
80
None
DVT
Rd
5
Results
Absolute
ASA
LMWH
difference,
P-value
N=176
N=166
%
Safety analysis, n (%)
Minor bleeding
0
1 (0.60)
-0.60
0.302
Gastrointestinal
0
1 (0.60)
--
6
Conclusions
Thromboprophylaxis low incidence of VTE
Thromboembolic events in early phase
Thromboprophylaxis first 4-6 months
Conclusions
LMWH: standard prophylaxis
for MM patients treated with Lenalidomide
ASA: possible alternative in
- low-risk patients
- long term prophylaxis
7
We Are Grateful to All Patients, Nurses and
Physicians of the Participating Centers
1. ALESSANDRIA
Levis, Baraldi
39. GENOVA
Carella, Spriano
77. RIMINI
Pasquini, Fattori
2. ANCONA
Leoni, Offidani
40. GENOVA
Bacigalupo, Dominietto
78. RIONERO VULTURE
Musto
3. AOSTA
Di Vito
41. IVREA
Girotto, Aitoro
79. RIETI
Capparella
4. ASCOLI PICENO
Galieni
42. LATINA
De Blasio
80. ROMA
Foà, Petrucci
5. ASTI
Favro, Ciravegna
43. LATINA
Cimino
81. ROMA
De Fabritiis, Caravita
6. AVELLINO
Cantore, Volpe
44. LECCE
Di Renzo
82. ROMA
Andriani
7. AVIANO
Tirelli, Rupolo
45. MATERA
Fragasso
83. ROMA
Annino, Bongarzoni
8. BARI
Vacca, Ria
46. MESSINA
Brugiatelli
84. ROMA
Leone, De Stefano
9. BARI
Liso
47. MESSINA
Musolino
85. ROMA
Petti, Pisani
10. BELLUNO
Pianezze
48. MILANO
Corradini, Montefusco
86. ROMA
Majolino, De Rosa
11. BENEVENTO
Di Lonardo, Vallone
49. MILANO
Morra
87. ROMA
Amadori
12. BERGAMO
Rambaldi, Galli
50. MILANO
Ciceri
88. ROMA
Avvisati
13. BOLOGNA
Baccarani,Cavo
51. MILANO
Lambertenghi, Baldini
89. ROMA
Recine
14. BOLZANO
Cortellazzo, Pescosta
52. MILANO
Gianni
90. ROZZANO
Santoro, Nozza
15. BRA
Vanni, Stefani
53. MODENA
Marasca
91. S. G. ROTONDO
Cascavilla, Falcone
16. BRESCIA
Rossi, Crippa
54. MODENA
Sacchi
92. SASSARI
Dore, Podda
17. BRESCIA
Russo, Malagola
55. MONZA
Pogliani, Rossini
93. SIENA
Lauria, Gozzetti
18. BRINDISI
Quarta
56. NAPOLI
Pane,Catalano
94. TARANTO
Mazza, Casulli
19. CAGLIARI
Angelucci, Derudas
57. NAPOLI
Ferrara
95. TERNI
Liberati
20. CAGLIARI
La Nasa, Ledda
58. NAPOLI
Mettivier
96. TORINO
Boccadoro
21. CAMPOBASSO
Storti
59. NOCERA INF.
D'Arco, Califano
97. TORINO
Pregno, Benevolo
22. CANDIOLO
Aglietta, Capaldi
60. NOVARA
Gaidano, Rossi
98. TORINO
Tarella, Gottardi
23. CATANIA
Di Raimondo
61. NUORO
Gabbas
99. TREVISO
Gherlinzoni
24. CATANZARO
Peta, Piro
62. ORBASSANO
Saglio, Guglielmelli
100. TRICASE
Pavone
25. CATTOLICA
Pasquini
63. PADOVA
Semenzato, Zambello
101. TRIESTE
De Sabbata
26. CESENA
Guardigni
64. PALERMO
Mirto, Cangialosi
102. UDINE
Fanin, Patriarca
27. CIRIE'
Girotto, Freilone
65. PARMA
Rizzoli, Giuliani
103. VENEZIA
Chisesi
28. COSENZA
Morabito
66. PAVIA
Lazzarino, Corso
104. VERBANIA
Montanara, Luraschi
29. CREMONA
Lanza
67. PERUGIA
Martelli, Ballanti
105. VERCELLI
Santagostino
30. CUNEO
Gallamini, Grasso
68. PESARO
Visani, Leopardi
106. VERONA
Pizzolo, Meneghini
31. FIRENZE
Bosi/Nozzoli
69. PESCARA
Fioritoni, Spadano
107. VICENZA
Rodeghiero, Elice
32. FOGGIA
Capalbo
70. PIACENZA
Cavanna, Lazzaro
108. VITERBO
Montanaro
33. FORLI'
Amadori, Gentilini
71. PINEROLO
Griso
109. ISRAEL
Nagler
34. FROSINONE
Sala
72. PISA
Petrini/Benedetti
110. JERUSALEM
Ben Yehuda
35. GALLARATE
Mozzana, Ciambelli
73. POTENZA
Ricciuti, Vertone
111. KEFAR SABAH
Manor
36. GENOVA
Gobbi, Canepa
74. RAVENNA
Zaccaria, Cellini
112. ZERIFIM
Kornberg
37. FORLI'
Amadori, Gentilini
75. REGGIO CALABRIA
Nobile, Callea
113. HAIFA
Attias
38. GENOVA
Gobbi, Canepa
76. REGGIO EMILIA
Gugliotta, Masini
8