Supportive Care
imf hotLine coordinators ansWer your Questions
The IMF Hotline 800-452-CURE (2873) consistently provides cal ers with the best information about myeloma
in a caring and compassionate manner. The Hotline is staffed by Nancy Baxter, Debbie Birns, Paul Hewit ,
and Missy Klepetar. The phone lines are open Monday through Friday, 9 a.m. to 4 p.m. (Pacific Time).
To submit your question online, please email TheIMF@myeloma.org
I am receiving VELCADE® as part
of Salamanca, Spain, concluded that low
of my treatment regimen. Is there a
rates of PN were observed after a modi-
consensus among myeloma doctors
fied bortezomib regimen that consisted
on VELCADE dosing?
of one 6-week cycle administered twice
Bortezomib (VELCADE®) is an effective
a week, followed by subsequent cycles
and widely used treatment for mul-
in which bortezomib was administered
tiple myeloma. It can be given alone,
in a weekly schedule (four weekly bort-
in combination with dexamethasone,
ezomib doses at 1.3 mg/m2 followed by
or in a variety of three- and four-drug
one week of rest).
combinations. Because of bortezomib's
Based on these trial results and the
effectiveness, it is essential to ensure
combined clinical experience of the
that patients are able to tolerate it well
IMWG experts, the IMWG concluded
and not discontinue receiving bortezomib infusions because of side effects.
that weekly bortezomib dosing and earlier detection of PN are therapeutic
Peripheral neuropathy (PN) ­ which causes numbness, tingling, and/
options to minimize the risk of neuropathy. Specific guidelines for deter-
or sometimes pain in the hands, arms, feet, and/or legs ­ is a common
mining bortezomib dose, which will soon be published in an IMWG paper,
problem among myeloma patients. Myeloma itself can cause PN, as can
are the following:
diabetes mellitus. Two of the most common novel therapies for myeloma,
· Patients who have no PN can be treated with bortezomib in the traditional
thalidomide (Thalomid®) and bortezomib, can also cause PN or worsen
twice weekly schedule.
pre-existing PN. Because the goal of any treatment for myeloma is to attack
the disease while preserving the patient's quality of life, it is important to be
· Patients with low-level neuropathy (defined as "Grade 1" using the
aware of this potential problem and to nip it in the bud before it becomes
National Cancer Institute's common toxicity criteria: numbness, weak-
a debilitating and permanent condition.
ness, and/or loss of reflexes, but without any pain or loss of function in
performing the activities of daily living) should be carefully evaluated by
At a meeting of the International Myeloma Working Group (IMWG) that
their physicians for the existence of PN risk factors and managed appro-
took place in June 2010 in Barcelona, Spain, the myeloma experts who
priately. Consideration should be given to administering bortezomib
were gathered from around the world addressed many key questions,
once weekly at a starting dose of 1.3 mg/m2.
including, "How do we minimize the risk of neuropathy?" To answer this
question, the experts examined important new clinical trial data that would
· For patients treated with bortezomib who develop Grade 1 neuropathy
enable them to draw up a guideline for bortezomib dosing with an eye to
who are experiencing pain, or those who have no pain but whose neu-
reducing the incidence of PN.
ropathy limits their ability to perform daily living activities (Grade 2),
consideration should be given to change bortezomib to a reduced dose
Clinical trials are the vehicle through which new drugs and drug combina-
of 1.3 mg/m2 once per week, as an alternative to the current package
tions are tested, and are often also the means through which new dosing
insert recommendation of reducing bortezomib dose to 1.0 mg/m2 twice
strategies are determined. Results of an Italian study group (GIMEMA)
weekly.
phase III randomized clinical trial, led by the University of Torino's Drs.
Antonio Palumbo and Mario Boccadoro, that compared VMPT (VELCADE,
· Patients treated with bortezomib who have Grade 2 neuropathy with
melphalan, prednisone, and thalidomide) followed by VT maintenance,
pain, or Grade 3, which is defined as severe pain, weakness, sensory
versus VMP followed by no maintenance, as first-line therapy in patients
alteration or numbness, and/or pain severely interfering with activities
ineligible for stem cell transplant were presented at the December 2009
of daily living, and needing bracing or assistance to walk, should not be
meeting of the American Society of Hematology (ASH) and at the June
given bortezomib until their side effects improve. When the PN improves,
2010) meeting of the American Society of Clinical Oncology (ASCO). During
consideration should be given to restarting bortezomib at 1.0 mg/m2
this trial, the study was amended to schedule bortezomib weekly (four
once per week (the current package insert recommendation includes
doses weekly at a dose of 1.3 mg/m2 followed by one week of rest) instead
restarting bortezomib at 0.7 mg/m2).
of the traditional twice weekly schedule, in order to reduce the rates of PN.
As always, we urge you to discuss this information with your hematologist/
The study investigators, having analyzed the data from the completed trial,
oncologist, and to report any and all symptoms of PN to your healthcare
noted, "Compared to twice weekly, the weekly infusion of bortezomib sig-
team AS SOON AS YOU EXPERIENCE THEM. Do not ignore any numbness,
nificantly reduced the incidence of PN without affecting outcome."
weakness, tingling, or pain you feel in your fingers, hands, arms, toes, feet,
In a phase III randomized study by the Spanish Myeloma Group (PETHEMA/
or legs. By reporting any and all symptoms as soon as possible, you enable
GEM) that compared VMP versus VTP followed by maintenance with VT or VP
your doctor to take prompt action to prevent what could become a debili-
as first-line therapy for myeloma, Dr. María Victoria Mateos of the University
tating and ongoing problem. mt
800-452-CURE(2873)
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