Roma February 14, 2005  GIMEMA
Stresa May 17, 2008  EMNTG
IF AT FIRST AN IDEA IS NOT ABSURD,
THEN THERE IS NO HOPE FOR IT
L’esperienza
dell’European Myeloma
Network Trialist Group
SURVIVAL OF COOPERATIVE GROUPS
• Research is moving to China, India where costs are lower
• Companies prefer big groups for studies of global impact
• Small groips are dying
YESTERDAY
TODAY
SWEDEN
AUSTRALIA
FINLAND
NORWAY
DENMARK
UNITED KINGDOM
NETHERLANDS
ISRAEL
POLAND
GERM ANY
CZECH
REPUBLIC
AUSTRIA
SPAIN
ITALY
GREECE
TURKEY
A RANDOMIZED PHASE III STUDY TO COMPARE BORTEZOMIB, MELPHALAN,
PREDNISONE (VMP) WITH HIGH DOSE MELPHALAN FOLLOWED BY
BORTEZOMIB, LENALIDOMIDE, DEXAMETHASONE (VRD) CONSOLIDATION AND
LENALIDOMIDE MAINTENANCE IN PATIENTS WITH NEWLY DIAGNOSED
MULTIPLE MYELOMA
INDUCTION 1500 pts
ITALY
3 VCD + CY
4 VMP (500 pts)
NONE
VRD
Maintenance
1 HDM (500 pts)
NONE
VRD
Maintenance
NETHERLAND AND NORDIC
GERMANY
2 HDM (500 pts)
NONE
VRD
Maintenance
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO
DETERMINE THE EFFICACY AND SAFETY OF CYCLOPHOSPHAMIDE,
LENALIDOMIDE AND DEXAMETHASONE (CRD) versus MELPHALAN (200 mg/m2)
FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE
MYELOMA SUBJECTS
EAST EUROPE
INDUCTION
660 pts RD (4 cycles)
ARM A (190 pts)
ARM B (190 pts)
CRD X 6 courses
MEL200 (1-2
cycles)
Maintenance
Maintenance
ARM A1
ARM A2
ARM B1
ARM B2
RP
R
RP
R
AUSTRALIA
A PHASE 3, INTERGROUP MULTICENTRE, RANDOMIZED, CONTROLLED 3 ARM
PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF
LENALIDOMIDE IN COMBINATION WITH DEXAMETHASONE (Rd) VERSUS
MELPHALAN, PREDNISONE AND LENALIDOMIDE (MPR) versus
CYCLOPHOSPHAMIDE, PREDNISONE AND LENALIDOMIDE (CPR) IN NEWLY
DIAGNOSED MULTIPLE MYELOMA SUBJECTS
ITALY
INDUCTION
660 pts
ARM A (220 pts)
ARM B (220 pts)
ARM C (220 pts)
Rd X 9 courses
MPR X 9 courses
CPR X 9 courses
Maintenance
Maintenance
Maintenance
ARM A1
ARM A2
ARM B1
ARM B2
ARM C1
ARM C3
R
RP
R
RP
R
RP
GERMANY
Legislazione no profit:
traferimento esiti ricerca scientifica
Bortezomib
(twice-weekly)
Bortezomib
(once weekly)
56%
58%
Grade 3/4
14%
2%
Discontinuation
16%
4%
2-year PFS
Sensory PN
• Canada

Bortezomib infusione settimanale
• Italia

Permane infusione bisettimanale
Palumbo et al. ASH 2009 (abstract 128); oral presentation
CENTRAL ORGANIZATION
PRECLINICAL/LAB
OFFICE
GRANT OFFICE
FINANCIAL OFFICE
CLINICAL TRIAL
OFFICE
LOCAL ORGANIZATION
LAB AND BIOBANKING
Support to research
•Phase I unit
•Financial office
•Legal office
•Patent office
•Grant office
•Data managing office
•Statistical office
 Fondazione
DISTRICT ORGANIZATION
PHASE I/II STUDIES
• CARFILZOMIB
• POMALIDOMIDE
• BORTEZOMIB SC.
• CNTO
Meta analysis and retrospective studies
MP versus MPT for previously untreated elderly patients with multiple
myeloma: A meta analysis of survival of 1682 individual patient data
from 6 randomized clinical trials.
A. Waage, A. P. Palumbo, P. Fayers, M. Beksac, C. Hulin, J. Y. Mary, S. Bringhen, P. Sonneveld, P.
Wijermans, T. Facon, NMSG, GIMEMA, TMSG, HOVON, IFM, European Myeloma Network; St. Olavs
Hospital/NTNU, Trondheim, Norway; Divisione di Ematologia dell'Università di Torino, A.O.U. S.
Giovanni Battista, Torino, Italy; University of Aberdeen, Aberdeen, Scotland; Ankara University,
Ankara, Turkey; Department of Hematology, University Hospital, Nancy, France; INSERM U717, Paris,
France; Erasmus MC, Rotterdam, Netherlands; Hospital Leyenburg, Hague, Netherlands; Hopital
Huriez, Service des Maladies du Sang, Lille, France
GIMEMA
IFM I
IFM II
NMSG
HOVON
TMSG
Age, Years
> 65
65-74
≥ 75
> 65
> 65
> 55
No of pts
331
321
229
354
333
114
Guidelines
The use of bisphosphonates in multiple
myeloma
Terpos E, Sezer O, Croucher PI, García-Sanz R,
Boccadoro M, San Miguel J, Ashcroft J, Bladé J, Cavo M,
Delforge M, Dimopoulos MA, Facon T, Macro M, Waage A,
Sonneveld P; European Myeloma Network.
Ann Oncol. 2009 Aug;20(8):1303-17. Epub 2009 May 22.
Review.PMID: 19465418
PubMed.gov publications
2010:
19 publications
2009:
20 publications
2008:
18 publications
2007:
11 publications
2006:
8 publications
2005:
7 publications
EMNTG
Publications: 2010
J Clin Oncol. 2010 May 1;28(13):2259-66.
J Clin Oncol. 2010 Apr 20;28(12):2077-84.
J Clin Oncol. 2010 Mar 20;28(9):1599-605.
J Clin Oncol. 2010 Feb 10;28(5):800-7.
Blood. 2010 Mar 25;115(12):2332-3.
Blood. 2010 Mar 11;115(10):1873-9.
Lancet Oncol. 2010 Jan;11(1):3-4.
Leukemia. 2010 Apr 22.
Leukemia. 2010 Apr 8.
Conclusion
• Important global cooperative group
• Relevant phase III studies
• 80% of the new molecules are within the group
• More trials than PIs
Take home message
• Specialization Eccellenti in 1 cosa o mediocri in 100
•Team effort
Delega e sinergia fra eccellenze
• Governance
Studi di fase 3 blindati
• Freedom
Studi di fase 1-2 liberi
• Support
Clinico, legale, segretariale, etc
We Are Grateful to All Patients, Nurses,
Physicians Insitutions of the Participating Centers
1. ALESSANDRIA
2. ANCONA
3. AOSTA
4. ASCOLI PICENO
5. ASTI
6. AVELLINO
7. AVIANO
8. BARI
9. BARI
10. BELLUNO
11. BENEVENTO
12. BERGAMO
13. BOLOGNA
14. BOLZANO
15. BRA
16. BRESCIA
17. BRESCIA
18. BRINDISI
19. CAGLIARI
20. CAGLIARI
21. CAMPOBASSO
22. CANDIOLO
23. CATANIA
24. CATANZARO
25. CATTOLICA
26. CESENA
27. CIRIE'
28. COSENZA
29. CREMONA
30. CUNEO
31. FIRENZE
32. FOGGIA
33. FORLI’
34. FROSINONE
35. GALLARATE
36. GENOVA
Levis, Baraldi
Leoni, Offidani
Di Vito
Galieni,
Favro
Cantore, Volpe
Tirelli, Rupolo
Dammacco, Ria
Liso
Pianezze
Di Lonardo, Vallone
Rambaldi, Galli
Baccarani,Cavo
Cortellazzo, Pescosta
Vanni, Stefani
Rossi, Crippa
Russo, Malagola
Quarta
Angelucci, Derudas
La Nasa, Ledda
Storti
Aglietta, Capaldi
Giustolisi,Di Raimondo
Peta, Piro
Pasquini
Guardigni
Girotto, Freilone
Morabito
Morandi
Gallamini, Grasso
Bosi/Nozzoli
Capalbo
Amadori, Gentilini
Sala
Ciambelli
Gobbi, Canepa
37. FORLI’
38. FROSINONE
39. GALLARATE
40. GENOVA
41. GENOVA
42. GENOVA
43. IVREA
44. LATINA
45. LATINA
46. LECCE
47. MATERA
48. MESSINA
49. MESSINA
50. MILANO
51. MILANO
52. MILANO
53. MILANO
54. MILANO
55. MODENA
56. MODENA
57. MONZA
58. NAPOLI
59. NAPOLI
60. NAPOLI
61. NOCERA INF.
62. NOVARA
63. NUORO
64. ORBASSANO
65. PADOVA
66. PALERMO
67. PARMA
68. PAVIA
69. PERUGIA
70. PESARO
71. PESCARA
72. PIACENZA
Amadori, Gentilini
Sala
Ciambelli
Gobbi, Canepa
Carella, Spriano
Bacigalupo, Dominietto
Girotto, Aitoro
De Blasio
Cimino
Di Renzo
Fragasso
Brugiatelli
Musolino
Corradini, Montefusco
Morra
Ciceri
Lanbertenghi, Baldini
Gianni
Torelli
Sacchi
Pogliani, Rossini
Rotoli,Catalano
Ferrara
Mettivier
D’Arco, Califano
Gaidano, Rossi
Gabbas
Saglio, Guglielmelli
Semenzato, Zambello
Mirto, Cangialosi
Rizzoli, Giuliani
Lazzarino, Corso
Liberati, Nunzi
Visani, Leopardi
Fioritoni, Spadano
Cavanna, Lazzaro
73. PINEROLO
74. PISA
75. POTENZA
76. RAVENNA
77. REGGIO CAL.
78. REGGIO EMILIA
79. RIMINI
80. RIONERO VULTURE
81. RIETI
82. ROMA
83. ROMA
84. ROMA
85. ROMA
86. ROMA
87. ROMA
88. ROMA
89. ROMA
90. ROMA
91. ROMA
92. ROZZANO
93. S. G. ROTONDO
94. SASSARI
95. SIENA
96. TARANTO
97. TORINO
98. TORINO
99. TORINO
100. TREVISO
101. TRICASE
102. TRIESTE
103. UDINE
104. VENEZIA
105. VERBANIA
106. VERCELLI
107. VERONA
108. VICENZA
109. VITERBO
Griso
Petrini/Benedetti
Ricciuti, Vertone
Zaccaria, Cellini
Nobile, Callea
Gugliotta, Masini
Pasquini, Fattori
Musto
Capparella
Foà, Petrucci
De Fabritiis, Caravita
Andriani
Annino, Bongarzoni
Leone, De Stefano
Petti, Pisani
Majolino, De Rosa
Amadori
Avvisati
Recine
Santoro, Nozza
Cascavilla, Falcone
Dore, Podda
Lauria, Gozzetti
Mazza, Casulli
Boccadoro
Gallo, Pregno
Poccardi, Aragno
Foscolo, Gherlinzoni
Pavone
De Sabbata
Fanin, Patriarca
Chisesi
Montanara, Luraschi
Santagostino
Pizzolo, Meneghini
Rodeghiero, Elice
Montanaro