CIRB Approved 2/24/05
Frequently asked
Q uestions...
ABOUT E4A03: A CLINICAL
What are the drugs being used in this trial?
TRIAL FOR PEOPLE NEWLY-
· Dexamethasone is a type of steroid approved by the FDA for
DIAGNOSED WITH MULTIPLE
many diseases, and has been proven to be effective against both
MYELOMA
newly-diagnosed and advanced myeloma.
· Thalidomide is a drug which has been shown to be effective for
The Eastern Cooperative Oncology
treatment of patients with newly-diagnosed and advanced
Group (ECOG) prepared this fact
myeloma. Thalidomide is considered an investigational drug when
sheet to help you understand this
used for multiple myeloma. Approval of thalidomide use in
cancer clinical trial.
myeloma treatment is currently being considered by the FDA.
Note that thalidomide causes birth defects. You must use birth
What is a clinical trial?
control if you take thalidomide.
A clinical trial is a study conducted by
· Lenalidomide is an investigational drug, not yet approved by FDA,
doctors to test new medications or new
which is chemically similar to thalidomide. In studies so far,
combinations of medications. This trial --
lenalidomide has shown encouraging results in advanced
ECOG E4A03 -- is what doctors call a
myeloma. Because of its similarity to thalidomide, you must use
"Phase 3" trial. In this trial, we will
birth control if you take lenalidomide.
compare an encouraging new treatment
to the standard available treatment for
What are some of the side effects caused by these medications?
multiple myeloma.
Some of the most common side effects of thalidomide are sleepiness,
rash, constipation, and tingling or numbness in the hands and feet.
What is being tested in this trial?
Thalidomide causes birth defects. You must use birth control if you take
This trial is testing two variations of treat-
thalidomide. Lenalidomide is chemically similar to thalidomide, but in
ment with dexamethasone (a steroid) and
preliminary studies has fewer side effects. However, lenalidomide may
CC-5013 (a new anti-myeloma drug):
cause blood abnormalities that may lead to fatigue, increased risk of
1) To see if a lower dose (amount) of
bleeding, or infection. Dexamethasone may cause the body to retain
dexamethasone has the same effect
salt and fluid and/or cause insomnia and mood swings.
as a higher dose without as many
side effects when it is given with an
As always, remember to tell your doctor or nurse about any changes in
investigational drug called CC-5013
your health and any other medications you may be taking. Your health-
(also known as lenalidomide or
care team can help you manage side effects and help you complete
RevlimidTM;
your therapy as comfortably as possible.
2) If lenalidomide doesn't work well, to
see if switching to thalidomide is
What will I have to do on the clinical trial?
more effective.
If you decide to participate in this trial, your doctor will perform several
tests before you begin taking your medication. These include:
This trial also includes laboratory tests
· Blood and urine tests;
that will analyze samples of blood and
· Bone marrow biopsy; and
bone marrow to understand how the
· Bone x-rays.
different treatments affect myeloma cells.
No additional biopsies will be done to
You would most likely need to have these tests anyway as part of your
obtain this material, only what's required
routine care for multiple myeloma. Some of these tests will be repeated
for the treatment part of the study.
occasionally during the trial. Your doctor or nurse will help you set up a
Neither you nor your insurance company
schedule for your tests.
will be billed for these tests.
The trial is designed so that you will not have a choice about whether
you receive the higher or lower dose of dexamethasone. All patients will
receive lenalidomide when they start treatment. Remember that
dexamethasone is a standard drug for the treatment of newly-diagnosed
and advanced myeloma. No one in this trial will receive a "placebo," a
type of pill that has no effect.
www .ecog.org
Will insurance cover the cost of this trial?
Who is conducting the trial?
Medicare covers the routine costs of care
The Eastern Cooperative Oncology Group (ECOG) is conducting this
required in clinical trials. Many other
trial. ECOG is one of the largest cancer research organizations in the
insurers also cover these costs. Coverage
United States. It has a network of researchers, physicians, and healthcare
may not, however, be the same from plan
professionals at public and private institutions across the country. ECOG
to plan. Please discuss these issues with
conducts clinical trials in all types of adult cancers. It receives funding
your healthcare provider and your insurer.
from the National Cancer Institute (NCI) and other sources. ECOG's goal
Thalidomide and lenalidomide, the
is to control, effectively treat, and ultimately cure cancer. ECOG provides
investigational drugs, will be provided at
research results to individuals and the medical community through
no cost to you.
scientific publications and professional meetings.
Is this trial right for me?
Where can I get more information?
To be accepted into this trial, you must
For more information about this trial, visit http://E4A03.myeloma.org
have been recently diagnosed with multi-
For more information about ECOG, visit http://www.ecog.org.
ple myeloma. You may not have received
For more information about cancer and clinical trials, visit:
any previous anti-myeloma therapy to be
The Coalition of National Cancer Cooperative Groups:
eligible for this trial. Men and women of
www.CancerTrialsHelp.org
all ethic groups can participate.
The National Cancer Institute (NCI) Cancer Information Service:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615,
If you would like to participate in this trial,
http://cancer.gov/clinical_trials for clinical trial information and
let your doctor know. Your doctor can tell
http://cancer.gov/cancer_information for more information
you whether this trial is right for you. If
about cancer.
you decide to participate, your doctor will
help you understand all the details of the
study through a process called "informed
consent" before you begin treatment on
the trial.
What if I change my mind after enrolling in
the trial?
You may stop treatment at any time --
please discuss your concerns with your
doctor. There are other treatments
available to you for myeloma.
Would my doctor stop my participation for
any reason?
Your doctor will carefully observe your
health throughout the trial. Your doctor
may stop your participation if:
· Your disease progresses;
· You have serious side effects;
· New information on treating
multiple myeloma becomes
available that may affect your
health or welfare.
2/05
www .ecog.org