Jointly sponsored by Postgraduate Institute for Medicine, the
International Myeloma Foundation, and Clinical Care Options, LLC
Multiple Myeloma:
Finding Your Way
gy Through the Treatment Maze--Selecting
the Best Treatment in the Era of Novel Agents
Friday, December 5, 2008
6:30 PM - 9:00 PM
Moscone Center
San Francisco, California
Supported by educational grants from Celgene, Genzyme Transplant, Lilly,
Millennium Pharmaceuticals, Inc., and Ortho Biotech.
Evidence-Based Approaches
for Induction Therapy
S. Vincent Rajkumar
Pf
Professor f
o Medi
dicine
Mayo Clinic
Scottsdale
Scotts
,
dale Arizona
Rochester,
Rochester Minnesota
Jack
Jac s
k o
s n
o v
n ille
v
,
ille Florida
Mayo Clinic College of Medicine
Mayo Clinic Comprehensive Cancer Center
Treatment of Myeloma
MP Era
2008
42% at 3 years
93% at 3 years
MTCG. J Clin Oncol. 1998;16:3832-3842.
Menon S, et al. Cancer. 2008;112:1522-1528.
MM 003: Thal/Dex vs Placebo/Dex: (A) TTP and (B) PFS
of Patients Receiving Thal/Dex (Yellow) vs Placebo/Dex (Blue)
Rajkumar SV, et al. J Clin Oncol. 2008;26:2171-2177.
Cop yrigh t © A m erican S oc ie t y o f C linical O ncolog y
IFM: VAD vs Vel-Dex*
VAD
Vel-D
e
ex
e
P Value
Evaluable Patients
N = 219
N = 223
CR
3.2%
9.9%
.004
CR + nCR
7.8%
19.3%
.0004
VGPR
19 2%
.
46 6%
.
< .0001
PR
65.8%
82.5%
< .0001
*Investigators' assessment for any response rate.
Harousseau JL, et al. ASCO 2008. Abstract 8505.
VTD vs TD
TD
%o
% fP
of atients
Patients
VTD
RESPONSE
TD
(n = 127)
P Value
(n = 129)
(n = 127)
CR + nCR
36
9
< .001
VGPR
60
27
< .001
<P
<
R
PR
7
20
003
.
Progression
0
5.5
.008
EBMT criteria (with added nCR and VGPR categories)
Cavo M, et al. ASH 2007. Abstract 73.
S0232: Progression-Free Survival
Len-Dex
P = 002
.
Dex
1-Yr PFS
LD:
77%
Len-Dex
Dex:
55%
Dex
Zonder J, et al. ASCO 2008. Abstract 8521.
ECOG E4A03 Phase
Phase III Trial
Days
1
8
15
22
28
Lenalidomide 25 mg PO Days 1-21
A
Total Dex
dose per
Dex
Dex
Dex
cycle =
D1-4
D9-12
D17-20
480 mg
Lenalidomide 25
25 mg
mg PO
PO Days
Days 1 21
-
Tot
To al
a Dex
Dex
B
dose per
D
D
D
D
e
e
e
e
cycle =
x
x
x
x
160 mg
D1
D8
D15
D22
Rajkumar SV, et al. ASCO 2007. Abstract 8025. Rajkumar SV, et al. ASH 2007. Abstract 74.
Overall Survival
Survival
Rajkumar SV, et al. ASH 2007. Abstract 74.
Ch i
o ce f
o I i
n ti
itial Th
Therapy
Transplant Candidates
Significant
Use in
Regimen
g
Route
DVT Risk
Neuropathy
py
Renal
Choice
Risk
Failure
Rd
Oral
Yes
No
No
Std Risk
Vd, CBD
IV
No
Yes
Ye
Yes
Ye
High Risk
Renal
VTD
IV
Yes
Yes
Yes
Failure
Rajkumar SV. ASCO ED. Book 2008.
VRD
· 66 evaluable pts
CR
26%
nCR
11%
71%*
VGPR
35%
PR (27%)
· Overall response
response rate:
rate: 98%
(95% CI: 87.4% to 99.9%)
Richardson PG, et al. ASCO 2008. Abstract 8520.
Key Trials
Trials
· SWOG S0777: Rd vs VRd
· ECOG E1A05: Vd vs VRd
· Evolution: VRd vs CBd vs VCRd
www.msmart.org
mSMART: Classification of
of Active
Active MM
MM
High Risk (25%)
Standard Risk (75%) *
· FISH
Del 17p
All oth
thers i
l
nc udi
ding:
t(4;14)*
t(14;16)
Hyperdiploid
· Cytogenetic deletion 13
t(11;14)
14)
· Cytogenetic hypodiploidy
t(6;14)
· PCLI 3%
*Patients with
ith t(4;14), b2M < 4
/
mg L
/L
d
an Hb 10 /dL
g
may have i t
n ermediate- ik
risk di
disease
Dispenzieri A, et al. Mayo Clin Proc. 2007;82:323-341; v4 Revised and updated: June 2008
Evidence-Based Approaches
for Induction Therapy
S. Vincent Rajkumar
Pf
Professor f
o Medi
dicine
Mayo Clinic
Scottsdale
Scotts
,
dale Arizona
Rochester,
Rochester Minnesota
Jack
Jac s
k o
s n
o v
n ille
v
,
ille Florida
Mayo Clinic College of Medicine
Mayo Clinic Comprehensive Cancer Center
Jointly sponsored by Postgraduate Institute for Medicine, the
International Myeloma Foundation, and Clinical Care Options, LLC
Multiple Myeloma:
Finding Your Way
gy Through the Treatment Maze--Selecting
the Best Treatment in the Era of Novel Agents
Friday, December 5, 2008
6:30 PM - 9:00 PM
Moscone Center
San Francisco, California
Supported by educational grants from Celgene, Genzyme Transplant, Lilly,
Millennium Pharmaceuticals, Inc., and Ortho Biotech.