Single Agent Lenalidomide in Newly Diagnosed
Multiple Myeloma: a Case Series
Rachid Baz, Mehul Patel, Elizabeth Finley-Oliver, Daniel Lebovic, Mohamad A. Hussein, Kena C. Miller,
Margaret Wood, Taimur Sher, Hong Liu, Kelvin Lee and Asher A. Chanan-Khan
Departments of Malignant Hematology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. Department of Medicine,
Roswell Park Cancer Institute, Buffalo, and NY. Celgene Corporation, Summit, N.J
ABSTRACT
BACKGROUND
RESULTS
Lenalidomide is a novel immunomodulatory agent with ability
From March 2007 to July 2009, seventeen patients with
Table 1. Patient characteristics
IMWG Response to single agent
Recently, lenalidomide and low dose dexamethasone was
to induce a immune mediated response in patients with B-cell
previously untreated multiple myeloma were treated with single
lenalidomide
found to result in superior overall survival compared to
cancers [1,2]. Preclinical evaluation reveals that this immune
agent lenalidomide at both institutions. Patient characteristics are
Characteristics
Number (%)
mediated response is dependant upon proliferation and activation of
summarized in Table 1. Most patients had ISS stage I myeloma
100
lenalidomid
lenalido
e
mid
and high dose
do
de
d xame
xa
tha
me
s
tha one. The immu
im
n
mu e
Median Age,
g, (y
( ears
y
)
70
ne
There were no reportd
ted
d
gra e 4 ht
hematologic toxi iti
c es. Gd
Grade 3
Tand NK cells that is mediated by lenalidomide and suppressed by
90
3
23
suppressive
effects
of
dexamethasone
can
antagonize
Range
(46-84)
80
steroids[3]. Several clinical observation are in line with this
neutropenia, anemia and thrombocytopenia were observed in 1, 1
g
Gender N (%)
in
70
lenalidomide immunomodulatory activity and may explain
SD
preclinical data: a retrospective analysis of the large clinical trial of
and 3 patients, respectively (Table 2).
There was no
29
Male
10 (59%)
60
MR
this observation. We attempt to evaluate the single agent
thromboembolic event reported. Lenalidomide dose was reduced
lenalidomide in combination with dexamethasone (the MM-009 and
espond
50
PR
Heavy Chain, N (%)
R
in six patients primarily due to the grade 3 hematologic toxicities
40
VGPR
activity of lenalidomide in newly diagnosed myeloma.
18
the MM-010 trials) revealed improved progression free survival
IgG
10 (59%)
rcent
30
CR
(noted above) and in one patient for grade 2 non-hematologic
e
(PFS) among patients whose dexamethasone dose was reduced due
P
12
IgA
5 (29%)
20
toxicities (rash, diarrhea, and fatigue). IMWG Responses are
to toxicity versus those patients who remained on high-d
g
ose
Light chain only
gy
2 (12%)
10
18
summarized in table
be 3.
3 Briefly,
ey, 76%
76
of
o patient
pe s achi
c eved
eved aMR
()
0
Records of patients with newly diagnosed symptomatic
dexamethasone[4]; similarly, the Eastern Cooperative Oncology
and better with single agent lenalidomide. The median time to
Light Chain, Lambda N (%)
10 (59%)
first response was 50 days (range 28-98 days) and median time to
Table 3. IMWG response to single agent lenalidomide
multiple myeloma treated with single agent lenalidomide at
Group study, E4A03, comparing lenalidomide and low dose
Durie Salmon Stage, N (%)
dexamethasone to lenalidomide and high dose dexamethasone
best response was 69 days (range 30-591 days). At a median
H. Lee Moffitt Cancer Center and Roswell Park Cancer
IIA
4 (24%)
demonstrated a better 1 and 2 years survival for the group that
follow up of 7 months (range 1-26), one patient died of
IIIA
13 (76%)
CONCLUSIONS
Institute were reviewed. Data was collected on disease
progressive disease (despite the addition of dexamethasone and
received a lower dose of dexamethasone[5].
Collectively these
International staging system, N (%)
characteristics,
demographics
and
treatment
outcomes.
subsequent therapies), six patients required the addition of
observations suggest that the immune mediated anti-tumor effects of
I
11 (65%)
To our knowledge, this is the first report on the single agent
dexamethasone for progression of the disease (Figure 1). Three of
Response
Respon s
se were
wer assess
e ed as per the
th In
I ternation
tern
a
ation l Myeloma
l
lenali
a domi
m de can be bett
bet er harn
har esse
es d
se
when used
use
alone (or
II
6 (35%)
()
activity of lenalidomide in newly
yy diagnosed myelom
y
a.
(or
these patients progressed f
a ter th
ddi
ea
tion of dh
dexamethasone to
Working Group criteria.
III
2 (12%)
independent of corticosteroids).
lenalidomide.
2microglobulin, (mg/L)

Single agent lenalidomide is active and produces
Median, (range)
2.84 (2.13-10.7)
responses in almost 76% of patients
Patients with 2m> 5.5mg/L
1 (5%)
RESULTS: From March 2007 to July 2009, seventeen

Hemoglobin, g/dL
The median time to first and most response is
patients with newly diagnosed multiple myeloma have been
METHODS
Patients with hemoglobin <10g/dL, N (%)
2 (11%)
comparable to what is reported for the combination of
lenalidomide and dexamethasone
treated with
wi
single
singl agent
ag
le
l nalidomid
nalido
e
mid at both
bot
in
i s
n tit
t u
it t
u ion
t
s
Median (range
(g )
11.6 (8.2-15.8)
ions.
This study was approved by the institutional review boards of
The median age was 70 years (range 46-84 years).

Based on this information, we plan to initiate a
both institutions. All patients who had previously untreated and
Cytogenetics, N (%)
Lenalidomide was generally well tolerated and no grade 4
Deletion 13q
4 (24%)
prospective study to investigate the merit of this
symptomatic multiple myeloma [13] who were treated with single
approach more formally.
hematologic toxicities were noted. The overall response rate
Deletion 17p
1 (6%)
agent lenalidomide as initial therapy (without corticosteroids) were
Fig. B
Not available
10 (59%)
(minimal response and better) was 76.5%. After a median
eligible for this analysis. The most common reason to omit
Lytic bone disease, N (%)
11 (65%)
follow up of 7 months (range 1-26), one patient died of
corticosteroids (dexamethasone) from the treatment regimen was
progres
progre sive di
d s
i ease (despite
pi
the additi
add on
iti
of de
d xamethason
xamethaso e
treating physic
py
ian discretion or patients preference. Lenalidomide
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T b
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ema l
o
i
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Chanan-Khan, A.A.,et al. J Clin Oncol, 2008. 26(9):
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Grade 2
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N (%)
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Fig. A
Thrombocytopenia
2 (12%)
3 (19%)
4..
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i iti
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ti
i
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d
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il
urvival f
o patients
ih
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id
om e
i
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(A) and with lenalidomide followed by lenalidomide and dexamethasone (B)
Conflict of Interest: Disclosures: Baz: Celgene: Membership on an entity's Board of Directors or
5..
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Advisory Committees, Research Funding. Off Label Use: Lenalidomide as a single agent in newly
patients with multiple myeloma.
p. abstract 74.
diagnosed myeloma. Hussein: Celgene: Employment
Poster Board No. III-804

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