5/12/2011
A randomized phase III study to compare
VMP with MEL-200 followed by VRD
consolidation and Lenalidomide maintenance
in newly diagnosed multiple myeloma patients
Michele Cavo
Bologna University School of Medicine
Seràgnoli Institute of Hematology
SWE
SW DE
D N
AUS
AU T
S RALIA
I
FIN
FI LAN
A D
NORW
R A
W Y
A
DENM
N AR
A K
R
UNITE
IT D KINGD
G O
D M
O
NETHE
H R
E L
R A
L N
A D
N S
ISRA
R E
A L
POLA
POL N
A D
GERM
R AN
A Y
CZEC
E H
REPUB
U L
B I
L C
AUS
AU T
S RIA
SWI
SW TZE
T RL
R AN
A D
PORT
R UG
U A
G L
A
SPAI
A N
I
ITAL
A Y
L
GR
G EEC
R
E
TUR
TU K
R E
K Y
1

---

5/12/2011
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
What is the best timing of ASCT in the
novel agent era?
­ ShouldASCTcontinuetobe
performed up-front?
­ Can ASCT up-front be challenged by
novel agents and delayed at the time
of relapse?
­ Is it possible to tailor timing of ASCT
according to the single patient's risk?
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
Can ASCT be delayed at the time of relapse?
Fermand et al, J Clin Oncol 2005; 23:9227-33
2

---

5/12/2011
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
Can ASCT be delayed at the time of relapse?
Barlogie et al, J Clin Oncol 2006; 24:929-36
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
What is the best timing of ASCT in the
novel agent era?
­ Should ASCT continue to be performed
up-front? (Pros)
Patients are usually more fit early in the
course of the disease
ASCT
provides
additional
tumor
reduction even in face of high response
rates obtained with novel-agent-based
therapies
3

---

5/12/2011
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
What is the best timing of ASCT in the novel
agent era?
­ Can ASCT be delayed at the time of
relapse? (Cons)
A fraction of patients cannot be expected
to be fit enough to receive high-dose
therapy
The probability to attain CR or a deeper
response may be lower than at the onset of
the disease
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
Which is the role of double ASCT in the
novel agent era?
Absence of nCR+CR
Attal et al, New Engl J Med 2003; 349:2495-502
Cavo et al, J Clin Oncol 2007; 25:2434-41
4

---

5/12/2011
NEWLY DIAGNOSED MYELOMA <65 YEARS:
FACTS & QUESTIONS?
Which is the role of double ASCT in the
novel agent era?
­ Provided
that
immunophenotypic
and/or molecular response is/are the
primary endpoint(s), a second ASCT
might further contribute to improve
the depth of response
STUDY DESIGN
VCD x 3
CTX + PBSC collection
R
VMP x 4
MEL 200 x 1
MEL 200 x 2
optional
5

---