Newly diagnosed myeloma < 66 years
IFM / DFCI prospective study
Pr Philippe Moreau
on behalf of the IFM/DFCI
« optimal strategy »
Induction therapy
ASCT
Consolidation
Maintenance
VRD x 3
Melphalan
VRD x 2
Lenalidomide
200 mg/m2
1

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< 66 years, de novo
Pilot trial, IFM 2008-01,
« optimal strategy »
Induction therapy
ASCT
Consolidation
Maintenance
VRD x 3
Melphalan
VRD x 2
Lenalidomide
200 mg/m2
STUDY DESIGN
Open-label, multicenter, phase II study
in frontline MM pts < 65 yrs
Induction treatment = Cycles VRD 1,2 and 3 every 21 days
Lenalidomide 25mg/d (days 1 to 14)
Bortezomib 1.3mg/m2 (days 1, 4, 8, 11)
Oral Dexamethasone 40mg/d (days 1, 8, 14)
Response assessment
Peripheral Stem Cell Collection 5x106 /kg (cyclophosphamide 3g/m2 and G-CSF 5µg/kg/d)
Response assessment
ASCT
Melphalan 200mg/m2 on D-2 + Pegfilgrastim 6mg D2
Response assessment
Consolidation treatment = Cycles VRD 4 and 5, every 21 days
Response assessment
Maintenance therapy for 12 months
Lenalidomide 10mg/d for 3 months then 15mg/d if well tolerated
Roussel, ASH 2010
2

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RESPONSE RATES (ITT)
after Induction
after ASCT
after Consolidation
n%n
%
n
%
sCR
5
1710
3212
38
CR
263
10
3
10
CR+sCR
7
23
13
42
15
48
VGPR
12
39
8
26
11
36
VGPR
19
62
21
68
26
84
PR
10
32
7
23
3
10
ORR
29
94289129
94
SD
262
61
3
out of trial
0
1
3
1
3
total
31
100
31
100
31
100
Roussel, ASH 2010
RVD
Richardson et al, Blood 2010, online 12 april
Up to eight 21-day cycles
1 2
4 5
8 9
11 12
14
Bz
Bz
Bz
Bz
Dex
Dex
Dex
Dex
Lenalidomide
Phase II : Len 25, Btz 1.3, Dex : 20
3

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Best response to treatment overall
and in the phase II population
Response, n (%)
All pts (N=66)
Phase II (N=35)
CR
19 (29)
13 (37)
nCR
7 (11)
7 (20)
VGPR
18 (27)
6 (17)
PR
22 (33)
9 (26)
CR+nCR
26 (39)
20 (57)
CR+nCR+VGPR
44 (67)
26 (74)
At least PR
66 (100)
35 (100)
PFS according to receipt of ASCT
Receipt of ASCT did not affect 1-yr PFS (P = .38)
4

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IFM/DFCI 2009 Study
Newly Diagnosed MM patients
Randomize
RVDx3
Induction
RVDx3
CY (3g/m2)
MOBILIZATION
CY (3g/m2)
Collection
Goal: 5 x106 cells/kg
MOBILIZATION
Goal: 5 x106 cells/kg
Melphalan
200mg/m2* +
RVD x 5
ASCT
Consolidation
RVD x 2
Maintenance
Revlimid 12 mos
Revlimid 12 mos
SCT at relapse
MEL 200 mg/m2 if <65 yrs ,
>65 yrs 140mg/m2
IFM/DFCI 2009 Study
Newly Diagnosed MM patients
Primary end-point:
PFS, 30 months vs 39 months
1000 patients
5

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IFM/DFCI 2009 Study
Newly Diagnosed MM Patients
Randomize
RVDx3
RVDx3
CY (3g/m2)
MOBILIZATION
CY (3g/m2)
Goal: 5 x106 cells/kg
MOBILIZATION
Goal: 5 x106 cells/kg
Stratification ISS, FISH
Melphalan
Systematic GEP, CGH
200mg/m2* +
RVD x 5
ASCT
risk-adapted strategy
RVD x 2
Revlimid 12 mos
Revlimid 12 mos
SCT at relapse
MEL 200 mg/m2 if <65 yrs ,
>65 yrs 140mg/m2
IFM/DFCI 2009 Study
Newly Diagnosed MM patients
P.Richardson
M.Attal
K.Anderson
P.Moreau
N.Munshi
S.Rollet
C.Mathiot
C.Revta
H.Avet-Loiseau
E.Weller
S.Minvielle
Colleagues from 14 centres
Colleagues from 70 centres
Support: Celgene,
Millenium, Janssen
6

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