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Primary therapy of Waldenstrom macroglobulinemia (WM) with weekly bortezomib, low-dose dexamethasone, and rituximab (BDR): long-term results of a phase 2 study of the European Myeloma Network (EMN).
[waldenström macroglobulinemia]
In
this
phase
2
multicenter
trial
,
we
evaluated
the
activity
of
bortezomib
,
dexamethasone
,
and
rituximab
(
BDR
)
combination
in
previously
untreated
symptomatic
patients
with
Waldenström
macroglobulinemia
(
WM
)
.
To
prevent
immunoglobulin
M
(
IgM
)
"
flare
,
"
single
agent
bortezomib
(
1
.
3
mg
/
m
(
2
)
IV
days
1
,
4
,
8
,
and
11
;
21
-
day
cycle
)
,
was
followed
by
weekly
IV
bortezomib
(
1
.
6
mg
/
m
(
2
)
days
1
,
8
,
15
,
and
22
)
every
35
days
for
4
additional
cycles
,
followed
by
IV
dexamethasone
(
40
mg
)
and
IV
rituximab
(
375
mg
/
m
(
2
)
)
in
cycles
2
and
5
.
Fifty
-
nine
patients
were
treated
;
45
.
5
%
and
40
%
were
high
and
intermediate
risk
per
the
International
Prognostic
Scoring
System
for
WM
.
On
intent
to
treat
,
85
%
responded
(
3
%
complete
response
,
7
%
very
good
partial
response
,
58
%
partial
response
[
PR
]
)
.
In
11
%
of
patients
,
an
increase
of
IgM
≥
25
%
was
observed
after
rituximab
;
no
patient
required
plasmapheresis
.
After
a
minimum
follow-up
of
32
months
,
median
progression-free
survival
was
42
months
,
3
-
year
duration
of
response
for
patients
with
≥
PR
was
70
%
,
and
3
-
year
survival
was
81
%
.
Peripheral
neuropathy
occurred
in
46
%
(
grade
≥
3
in
7
%
)
;
only
8
%
discontinued
bortezomib
due
to
neuropathy
.
BDR
is
rapidly
acting
,
well
tolerated
,
and
nonmyelotoxic
,
inducing
durable
responses
in
previously
untreated
WM
.
Diseases
Validation
Diseases presenting
"peripheral neuropathy"
symptom
adrenomyeloneuropathy
esophageal squamous cell carcinoma
hodgkin lymphoma, classical
homocystinuria without methylmalonic aciduria
kallmann syndrome
krabbe disease
neuralgic amyotrophy
oculocutaneous albinism
pyruvate dehydrogenase deficiency
sneddon syndrome
systemic capillary leak syndrome
thoracic outlet syndrome
triple a syndrome
waldenström macroglobulinemia
x-linked adrenoleukodystrophy
zellweger syndrome
This symptom has already been validated