Newly Diagnosed Myeloma > 65 years
Facts and Questions
IFM perspectives
Thierry FACON
On behalf of IFM
FIRST: Lenalidomide + LD-dex vs. MPT
(IFM 07-01)
· Pts: Previously untreated MM pts >65 yrs old or not a candidate
for ASCT
· Primary Endpoint: Progression-free survival (PFS)
LD (28-day cycle)
Oral dexamethasone on day 1, 8, 15, 22
M
Treatment until
Oral lenalidomide once daily on days 1-21
progressive
disease (PD)
LD (28-day cycle; up to 18 cycles)
R
Oral dexamethasone on day 1, 8, 15, 22
Oral lenalidomide once daily on days 1-21
MPT (6-wk cycle; up to 12 cycles)
Oral melphalan and prednisone on days 1-4
Oral thalidomide once daily on days 1-42
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Enrollment Summary
· EU (196 centers) 1112
· NA (55 centers) 311
· APAC ( 45 centers) 200
12-May-
12-May 11
1
Confidential Information
3
Enrollment By Country
EU
Country
# sites screening
# patients screened
# patients randomized
Austria
10
51
41
Belgium
11
62
52
France
64
555
459
Germany
14
132
97
Greece
2
103
86
Italy
17
178
148
Ireland
0
0
0
Portugal
5
34
27
Spain
18
108
87
Sweden
3
23
19
Switzerland
6
28
26
UK
16
101
72
12-May-
12-May 11
1
Confidential Information
4
2

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Enrollment By Country
AsiaPac
Country
# sites screening
# patients screened
# patients randomized
Australia
17
103
72
New Zealand
3
16
12
China
3
52
49
South Korea
15
71
56
Taiwan
3
16
11
12-May-
12-May 11
1
Confidential Information
5
Enrollment By Country
NA
Country
# sites screening
# patients screened
# patients randomized
Canada
22
322
251
US
21
79
60
12-May-
12-May 11
1
Confidential Information
6
3

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FIRST: Lenalidomide + LD-dex vs. MPT
(IFM 07-01/MM020)
1623 patients randomized in 296 centers
. 537 patients in IFM centers
The population is as close to the real life population as possible
. 569 patients > 75 years (36%)
. Med age 73 years
. Patients with renal insufficiency were enrolled
(only pts receiving dialysis were excluded)
CARMYSAP (1) Trial
Phase I/II trial of carfilzomib plus melphalan and
prednisone in elderly untreated with MM
Primary objective : to identify the most appropriate dose
of carfilzomib in combination with a standard MP regimen
(Phase I), and to evaluate the efficacy of CMP in terms of
response rates (Phase II)
Nine 6-week cycles of carfilzomib (20. 20/27, 20/36...) on
days 1,2,8,9,22,23,29,30 in combination with MP on days
1-4.
After identification of the MTD, up to a total of 20 pts at
the MTD for the phase II part of the study
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CARMYSAP 2 Trial proposal
Multicenter open-label phase II randomized study of CMP in
untreated symptomatic elderly MM patients
The study would investigate weekly carfilzomib in combination
with MP
Primary endpoint : VGPR+CR rate
Patients randomly allocated to :
- Arm A: MTD demonstrated in the phase I/II Carmysap trial
- Arm B: A weekly Carfilzomib regimen with Carfilzomib
used at a higher dose level
Using Rd as a platform for a next step forward
· VRd ; new standard of care in the US, part of
IFM/DFCI trial in younger pts. Modified (little) VRd
in the elderly is worthwhile, using weekly Bz, and
likely SC Bz
· CRd and Rd + oral proteasome inhibitors also
promising
· Rd and HDAC inhibitors (Rd-Vorinostat)
· Rd-Elotuzumab (IFM committment in the
upcoming randomized phase 3)
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Jean-Paul Fermand
Philippe Moreau
Thierry Facon
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