Lenalidomide Maintenance after Autologous
Transplantation for Myeloma:
First Interim analysis of a prospective randomized
study of the Intergroupe Francophone du Myélome
(IFM 2005-02 trial)
By Michel Attal, Gerald Marit, Denis Caillot, Thierry Facon, Philippe Moreau, Cyrille
Hulin, Claire Mathiot, Hervé Avet-Loiseau, and Jean-Luc Harousseau.
for the
the
eI
e FM
IFM

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IFM 2005-02: Study design
Phase III randomized, placebo-controlled trial
N= 614 patients, from 78 centers, enrolled between 7/2006 and 8/2008
Patients < 65 years, with non-progressive disease, 6 months after
ASCT in first line
Randomization: stratified acc
cording to
to Beta
Beta-2m, del13, VGPR
VGPR
Consolidation:
Lenalidomide alone 25 mg/day p o
. .
days 1-21 of every 28 days for 2 months
Arm A=
Arm B=
Placebo
Lenalidomide
(N=307)
(N=307)
until relapse
10-15 mg/d until relapse
Primary end-point: PFS.
Secondary end-points: CR rate, TTP, OS, feasibility of long-term lenalidomide....
ASCT = autologous stem cell transplant.
IFM = Intergroupe Francophone du Myelome.

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IFM 2005-02 : PFS
PFS ffrom randomization
Ar
.
rm A
Arm B
P
(N=307)
(N=307)
Pi
Progression or D
t
ea h
th
143 (47%)
77 (25%)
Median PFS (m)
(m)
24 (21-
21 27)
NA
3-year post
yp
rando PFS
34%
68%
Hazard Ratio
1
046
<10-7
1
0.46
< 10-

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IFM 2005-02 : PFS from randomization
001.
750.
Rev
10 7
p<10-
500.
25
Placebo
0.
P1
P < 0 7
10-
000.
0
6
12
18
24
30
36
Placebo
Revlimid
Months

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IFM 2005-02: First Interim Analysis
(C t
u
f
o f
ff d t
a e: 4th
4th S
t
ep ember 2009)
Maintenance therapy with Lenalidomide:
· Is well tolerated:
Low discontinuation rate due to AE
No Grade 3-4 neuropathy
· Is superior to placebo:
54% reduction risk of progression (p
g( < 10-7)
In all stratified subgroups (response, ß2m, del 13)
A longer
longer follow-
follow up is requ
uired to appreciate the
the impact
of Lenalidomide on OS (Final analysis: 8/2010)

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