Download A Randomized Phase III Study of CC

IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
Appendix I
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
A Randomized Phase III Study of CC-5013 plus Dexamethasone versus CC-5013
plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide plus
Dexamethasone Salvage Therapy for Non-Responders
What is a research study?
You are being asked to take part in this study because you have newly diagnosed
multiple myeloma.
This is a clinical trial (a type of research study). Clinical trials include only patients who
choose to take part. Please take your time to make your decision and discuss it with
your friends and family.
Why is this study being done?
This research is being done because current therapy does not help everyone with your
disease and many of the commonly used therapies involve injections into the vein and
significant side effects.
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1/07
The purpose of this study is to find out what effects (good and bad) that the combination
of CC-5013 (lenalidomide) plus dexamethasone has on you and your multiple myeloma.
We are looking at different dose levels to see if a lower dose of dexamethasone gives
the same benefit as a higher dose without as many side effects. After an adequate
number of patients have been recruited to this portion of the study, we will study the
efficacy of aspirin compared to a blood-thinner called coumadin in preventing blood
clots (a common side-effect) among patients receiving CC-5013 with the higher dose of
dexamethasone in the remaining patients. This is being done to see if the more
powerful blood thinner coumadin can decrease the risk of blood clots better than aspirin.
For patients in whom CC-5013 therapy does not work well, we will test the effect of
switching from CC-5013 to thalidomide; while the drugs are chemically similar, they are
not the same, and one may be more effective than the other in certain patients.
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3/06
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How many people will take part in the study?
About 682 people will take part in this study.
What is involved in the study?
Please, first see the study plan on the last page of this form.
We will be comparing a standard dose of dexamethasone with a low dose of
dexamethasone when each is combined with CC-5013. After an adequate number of
patients have been recruited to this portion of the study (approximately 412), we will
study the efficacy of aspirin compared to a blood-thinner called coumadin in preventing
blood clots (a common side-effect) among patients receiving CC-5013 with the higher
dose of dexamethasone in the remaining (approximately 270) patients.
8/13/04
Page 1 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
Appendix I
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
1/07
1/07
1/07
●
CC-5013 is an investigational drug, not yet approved by the FDA, for the
treatment of myeloma, which is chemically similar to thalidomide. In studies so
far, CC-5013 has shown promising activity in advanced myeloma.
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Thalidomide is a drug which has recently shown promising benefit in patients
with newly diagnosed and advanced myeloma. Thalidomide is considered an
investigational drug when used for multiple myeloma; FDA approval for
thalidomide use in myeloma treatment is pending.
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Dexamethasone is a type of steroid approved by the FDA for many diseases,
and has been proven to be effective in both newly diagnosed and advanced
myeloma.
If you are in the first phase of the trial, you will be “randomized” into one of two study
groups (Group A or Group B) described below in the section called “Procedures.” If you
are in the second (expansion) phase of the trial, you will be randomized to one of two
study groups (Group S or Group T). Randomization means that you are put into a
treatment group by chance. You will have an equal chance of being placed in either
group. It is similar to the flip of a coin. You and your doctor will NOT be able to choose
which treatment you receive.
If you take part in this study, you will have the following tests and procedures. Some of
these tests would be done even if you do not take part in the study.
Tests
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Blood tests
Urine tests
Bone marrow biopsy
X-rays
While you are receiving treatment your blood and urine tests will be repeated once a
month to assess the effect of treatment on your myeloma. Once you have completed 4
months of treatment we will also repeat the bone marrow biopsy and bone x-rays to
assess the effect of treatment.
Procedures
Group A: If you are assigned to Group A you will be treated with CC-5013 and standard
dose dexamethasone. You will take 25 mg of CC-5013 once a day, for 21 days (days
1-21), and then have one week off with no CC-5013 (days 22-28). This 28-day period is
considered "one cycle." You will take 40 mg of dexamethasone daily on days 1-4, 9-12,
and 17-20 of this 28-day cycle in addition to CC-5013. If there are no signs to suggest
worsening of your myeloma, you will receive 4 "cycles" of this treatment, lasting a total
8/13/04
Page 2 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
11/05
3/06, 1/07
of 16 weeks. You will receive one aspirin per day (325mg) while receiving this
treatment, to prevent complications known to be caused by both your myeloma and the
treatment drugs. Specifically, the complications involve blood clots in the legs and
lungs. If you notice swelling in your legs, contact your doctor immediately. Your doctor
may choose to use other drugs to prevent these complications instead of aspirin.
Further therapy will be at your doctor’s discretion, but if you responded well to CC-5013,
you will have the option to continue receiving CC-5013 with dexamethasone as on this
protocol until your myeloma shows signs of worsening. If you do continue therapy
beyond 4 cycles, the dose of dexamethasone will be reduced to days 1-4 every 28
days.
Group S: If you are assigned to Group S, you will be treated with CC-5013 and
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standard dose dexamethasone. You will take 25 mg of CC-5013 once a day, for 21
days (days 1-21), and then have one week off with no CC-5013 (days 22-28). This 28day period is considered "one cycle." You will take 40 mg of dexamethasone daily on
1/07
days 1-4, 9-12, 17-20 of this 28-day cycle in addition to CC-5013. If there are no signs
to suggest worsening of your myeloma, you will receive 4 "cycles" of this treatment,
11/05
lasting a total of 16 weeks. You will receive one aspirin per day (325mg) while receiving
this treatment, to prevent complications known to be caused by both your myeloma and
the treatment drugs. Specifically, the complications involve blood clots in the legs and
11/05,1/07 lungs. If you notice swelling in your legs, contact your doctor immediately.
Further therapy will be at your doctor’s discretion, but if you responded well to CC-5013,
you will have the option to continue receiving CC-5013 with dexamethasone as on this
3/06,1/07 protocol until your myeloma shows signs of worsening. If you do continue therapy
beyond 4 cycles, the dose of dexamethasone will be reduced to days 1-4 every 28
days.
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1/07
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Group T: If you are assigned to Group T you will be treated with CC-5013 and standard
dose dexamethasone. You will take 25 mg of CC-5013 once a day, for 21 days (days
1-21), and then have one week off with no CC-5013 (days 22-28). This 28-day period is
considered "one cycle." You will take 40 mg of dexamethasone daily on days 1-4, 9-12,
and 17-20 of this 28-day cycle in addition to CC-5013. If there are no signs to suggest
worsening of your myeloma, you will receive 4 "cycles" of this treatment, lasting a total
of 16 weeks. You will receive coumadin (a commonly used blood thinner) while
receiving this treatment, to prevent complications known to be caused by both your
myeloma and the treatment drugs. Specifically, the complications involve blood clots in
the legs and lungs. If you notice swelling in your legs, contact your doctor
immediately. Further therapy will be at your doctor’s discretion, but if you responded
well to CC-5013, you will have the option to continue receiving CC-5013 with
dexamethasone as on this protocol until your myeloma shows signs of worsening. If you
do continue therapy beyond 4 cycles, the dose of dexamethasone will be reduced to
days 1-4 every 28 days. If you have not had any blood clotting issues during the first 4
cycles, you will stop taking coumadin and take aspirin, instead, for the same purpose of
preventing blood clots.
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Page 2 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
1/07
11/05
3/06
11/05
3/06
1/07
Group B: If you are assigned to Group B you will be treated with CC-5013 and low dose
dexamethasone. You will take 25 mg of CC-5013 once a day, for 21 days (days 1-21),
and then have one week off with no CC-5013 (days 22-28). This 28-day period is
considered "one cycle." You will take 40 mg of dexamethasone daily on days 1, 8, 15
and 22 of this 28-day cycle in addition to CC-5013. If there are no signs to suggest
worsening of your myeloma, you will receive 4 "cycles" of this treatment, lasting a total
of 16 weeks. You will receive one aspirin per day (325 mg) while receiving this
treatment, to prevent complications known to be caused by both your myeloma and the
treatment drugs. Specifically, the complications involve blood clots in the legs and
lungs. If you notice swelling in your legs, contact your doctor immediately. Your
doctor may choose to use other drugs to prevent these complications instead of aspirin.
Further therapy will be at your doctor’s discretion, but if you responded well to CC-5013,
you will have the option to continue receiving CC-5013 with dexamethasone as on this
protocol until your myeloma shows signs of worsening.
Groups C and D: Groups C and D are only for patients who have not responded
adequately to therapy on Group A or B by the end of 4 cycles. This means you will not
automatically join Group C or D when you finish your Group A or Group B treatment. If
you meet the criteria to join this second step, you will register to it and begin the new
treatment within 5 days of ending your Group A or B treatment. Group A patients may
register to Group C and Group B patients may register to Group D. If you enter Group
C or D, you will be treated with thalidomide and dexamethasone. You will take 200 mg
thalidomide once a day, at night for 28 days (four weeks). This 28-day period is
considered "one cycle." You will take dexamethasone at the same dosage as you
received in Groups A or B during this 28-day cycle in addition to thalidomide. You will
continue to receive aspirin or a drug of your doctors choice to prevent blood clots. If
there are no signs to suggest worsening of your myeloma, you will receive 4 "cycles" of
this treatment, lasting a total of 16 weeks. Further therapy will be at your doctor’s
discretion, but if you responded well to thalidomide, you will have the option to continue
receiving thalidomide with dexamethasone as on this protocol until your myeloma
shows signs of worsening. Patients who choose to continue protocol treatment after 4
cycles of treatment on Group C will begin to receive less dexamethasone (on days 1-4
of each cycle only). This is similar to the Group D dose schedule. Researchers think it
will reduce the chance of blood clots.
The Investigator enrolling you on the study treatment will provide you with a patient
diary. You will mark in the patient diary the date and exact number of pills taken and any
comments you might have regarding side effects. The diary will be used by your doctor
to make sure you are taking the medications correctly.
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How Long Will I Be in the Study?
We think you will be on the study treatment for at least 4 months; if you respond well to
treatment, you may continue treatment until your disease shows signs of worsening, at
the discretion of your treating doctor. If you do not respond well during the first 4
months, you may also need 4 more months of therapy in Group C or D. If you respond
8/13/04
Page 3 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
3/06
well in Group C or D, you may continue treatment until your disease shows signs of
worsening. Alternatively, you may be on the study treatment for less than 4 months if
your multiple myeloma worsens. Once you complete the study, we would like to keep
track of your medical condition for 7 years to look at the long-term effects of the study.
Your doctor may decide to take you off this study treatment if you have excessive side
effects, if your condition worsens, if new information is available, or for any reason felt to
be in your best interests.
You may stop participating at any time. However, if you decide to stop participating in
the study, we encourage you to talk to your doctor first.
What Are the Risks of the Study?
While on the study, you are at risk for the following side effects. CC-5013 or
thalidomide or dexamethasone may cause some, all or none of the side effects listed.
You should discuss these with your doctor. There may also be other side effects that
we cannot predict. Other drugs will be given to make side effects less serious and less
uncomfortable. Many side effects go away shortly after thalidomide and
dexamethasone are stopped, but in some cases side effects can be serious, longlasting, permanent, or life threatening. Death is rare, but possible.
Your doctor will check you closely to see if any of these side effects are occurring and
routine blood tests will be done to monitor the effects of treatment.
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Risks and side effects related to the CC-5013 plus dexamethasone regimens we
are studying in Groups A, B, S and T include:
Likely:
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Blood abnormalities, such as a decrease in the number of white blood cells, red
blood cells, platelet, and/or neutrophils. White blood cells are cells of your
immune system. A decrease in white blood cells and or neutrophils may lead to
fever and/or a life threatening infection. The red blood cells carry oxygen to your
organs. A decrease in red blood cells can lead to fatigue. A decrease in
platelets may lead to bleeding and require stopping treatment. An elevated
number of eosinophils, a type of white blood cell, may also be seen. A decrease
in another type of white blood cells may increase the risk of rare types of
infections, called opportunistic infections.
• Blood clots. These can be life threatening because they can dislodge and go to
the lungs. Recently, participants in this research study who were being treated
with CC-5013 and the standard dose of dexamethasone were found to be 4 to 5
times more likely to have blood clots develop in their legs and lungs. There were
more blood clots in this group than those who were treated with CC-5013 and the
lower dose of dexamethasone. Because of this, you will be asked to take an
aspirin tablet (325mg) once a day along with your treatment for the myeloma.
8/13/04
Page 4 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
3/06
3/06
3/06
3/06
Or, your doctor may decide to use some other anti-coagulation treatment, such
as warfarin (Coumadin), or enoxaparin (Lovenox). If you are treated with
warfarin or enoxaparin, you will not take the daily aspirin tablet. The risks of
blood clots may be higher when CC-5013 is taken along with erythropoietin, a
drug sometimes given to help keep blood counts normal during treatment.
• Skin rash which could be hives, welts or acne-like
• Fever with chills
• Fatigue with light headedness, dizziness or fainting
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Headache
Stomach and throat ulcers or worsening or irritation of existing ulcers
Increased weight around the stomach
Puffiness (especially in the face)
Retaining of salt and fluids which could cause an increase in blood pressure
A rise in the blood sugar, which may make you feel weak, tired and thirsty. You
may have difficulty thinking, palpitations, or loss of memory. Rarely, comas or
seizures may occur.
 Problems with the level of potassium in the blood. This may make you feel weak
and tired. Rarely, there may be irregular heartbeat or sudden death.
 Muscle weakness
 Brittle bones
 Menstrual changes
 Mood swings
 Trouble with sleeping
 Changes in personality
• Weight gain or loss
 Weakening of the immune system resulting in an increased risk of infections,
which may be life-threatening
• Pneumonia (an infection in your lungs)
 Tremors
• Sweating
11/05,3/06 Less
Likely
 Tumor lysis syndrome (a syndrome in which uric acid, potassium, and phosphate
are released into the blood as a result of tumor breakdown following
administration of the study drug). High levels of uric acid, potassium and
phosphate may negatively affect cardiac function and/or may result in poor
kidney function.
8/13/04
Page 5 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form

3/06
Worsening heart function. You may feel weak and short of breath. Leg swelling
or collection of fluid in various areas of your body may occur. Rarely there is a
risk of irregular heartbeat or sudden death.
 Abnormally fast or irregular heart beats
 Heart attack which can be life threatening
 Stroke which can be life threatening
• High or low blood pressure
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• Symptoms of hay fever such as sneezing, nasal stuffiness and post nasal drip
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3/06, 1/07
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Seizures (Convulsions)
Cellulitis (a spreading infection/swelling within the tissue under the skin)
Inflammation of the pancreas
Loss of appetite
• Confusion
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Dizziness
Passing gas
Upset stomach or heartburn
Swelling of the feet, legs, hands, and arms
Increase in blood test that indicate the kidneys may be functioning abnormally
Alteration in taste or loss of taste
Dehydration
Nausea
Vomiting
Dry skin
Pain in the abdomen, back, bone, chest, head, muscle, gums or other places in
the body
Joint pain from arthritis
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• Swelling of the sinuses
• Diarrhea
Rare, but serious:
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Fluid in the membrane that surrounds the lungs causing difficulty breathing
Kidney failure
Damage to the kidneys
Urge to urinate frequently or urgently
Vision changes such as blurry vision, flashing lights or floaters
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Page 6 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
3/06
3/06
3/06
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3/06
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Dry eyes
Damage to the retina of the eye
Obstruction of the lower intestines that causes severe constipation
Development of a hole in the lower intestine that causes a life-threatening
infection of the abdomen
• Hair loss either on the scalp or the rest of the body
• Increased sensitivity of the skin to the sun that could result in more severe
sunburns
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• Chest pain that could indicate the risk for a future heart attack
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High levels of uric acid in your blood. You may develop severe joint swelling or
problems passing urine because of a kidney stone or kidney failure.
● Decrease or increase in the amount of thyroid hormone
• Decrease in the amount of testosterone hormone
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Difficulty in thinking clearly
Alterations in mood such as feeling agitated, anxious or depressed
Experiencing hallucinations or experiencing thoughts that are not based in reality
Fainting
Lowered level of awareness
Difficulty breathing
Difficulty with normal speech
Swelling of the spinal cord (myelitis)
Leg and hand cramps
Numbness and tingling, which may be painful
Damage to the nerves
Worsening of liver function: you may have yellow discoloration of your eyes and
skin, swelling of the belly and legs, worsening mental function or even coma,
vomiting blood or passing blood during bowel movements.
Back pain
Itchy eyes
Blurry vision
Constipation or diarrhea
Bloated abdomen
Cough
Bleeding in the brain, genitourinary, or lungs that could be life-threatening
Increased blood clotting time with increased risk of bleeding
8/13/04
Page 7 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
3/06
1/07
• Abnormalities in proteins that regulate blood clotting that could result in either
bleeding or blood clots
 Ringing in the ears
 Inflammation at the back of the mouth and/or tongue
 Night sweats
 Anemia caused by the breakdown of blood cells
● Itching, and other allergic reactions (including severe allergic reactions with
fevers)
 Participants with glaucoma or a family history of glaucoma may experience a rise
of inner eye pressure or glaucoma
 Dexamethasone given for more than one year at doses of 15 mg or greater may
cause cataracts
 Dexamethasone may also affect the skin by causing stretch marks (stomach,
lower back, breasts, and groin area).
 Slow wound healing
 Increased sweating
 Easy bruising
 Continued use of dexamethasone (more than 25 mg for 2 weeks) can lower the
function of the adrenal glands. This drug may also alter the body's defense
system increasing the chance of infections.
 There may be a risk of added toxicity when dexamethasone is combined with
CC-5013.
Risks and side effects related to the thalidomide plus dexamethasone regimens
we are studying in Groups C and D include:
Likely
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Sleepiness: To minimize the effects of sleepiness on your life, the drug is
administered at night. Alcohol or sleeping pills can increase the effects of
sleepiness or other side affects and must not be taken while on thalidomide. You
should discuss this with your doctor
Trouble sleeping
Rash
Nerve damage which may cause permanent inability to use an arm or leg,
hearing loss, or loss of sensation, persistent numbness and tingling
Constipation: To avoid constipation a regular program of stool softeners is
recommended
Low white cell count, which may put you at risk for a life-threatening infection
Fatigue
Thyroid problems
8/13/04
Page 8 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
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Heart beat irregularities, slow heart beat
Worsening heart function. You may feel weak and short of breath. Leg swelling
or collection of fluid in various areas of your body may occur. Rarely there is a
risk of irregular heartbeat or sudden death.
Blood irregularities, such as anemia (“low blood”)
Breathing difficulties
Decreased sex drive
Stomach and throat ulcers or worsening or irritation of existing ulcers
Inflammation of the pancreas
Increased weight around the stomach
Puffiness (especially in the face)
Retaining of salt and fluids which could cause an increase in blood pressure
A rise in the blood sugar, which may make you feel weak, tired and thirsty. You
may have difficulty thinking, palpitations, or loss of memory. Rarely, comas or
seizures may occur.
Problems with the level of potassium in the blood. This may make you feel weak
and tired. Rarely, there may be irregular heartbeat or sudden death.
Muscle weakness
Brittle bones
Menstrual changes
Mood swings
Depression
Changes in personality, confusion
Weight gain
Weakening of the immune system resulting in increased risk of infections, which
may be life-threatening
Pneumonia (swelling in your lungs)
Dry skin, itching
Swelling of feet
Tremors
Less Likely
 Seizures (convulsions)
 Blood clots in legs. These can be life threatening because they can dislodge and
go to the lungs. To prevent blood clots your doctor may prescribe a blood thinner
usually given as an injection under the skin daily while you receive thalidomide.
 Heart attack, which can be life threatening
 Severe/life threatening skin rash
8/13/04
Page 9 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
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Pancreatitis
Decrease in blood supply to the brain (stroke), which can be life threatening
Kidney damage
A spreading infection/swelling within the tissue under the skin
Rare, but Serious
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Dry mouth
Headache
Increased appetite
Milky nipple discharge
Coordination difficulties while walking
Low platelets (may make you more likely to have bruising or bleeding)
Inflammation of the eye
Intestinal obstruction
Hepatitis
Decrease in blood pressure when standing quickly
Lightheadedness, dizziness or fainting
Bone pain
Hair Loss
Nausea, vomiting
Participants with glaucoma or a family history of glaucoma may experience a rise
of inner eye pressure or glaucoma
Dexamethasone given for more than one year at doses of 15 mg or greater may
cause cataracts
Dexamethasone may also affect the skin by causing stretch marks (stomach,
lower back, breasts, and groin area)
Slow wound healing
Increased sweating
Easy bruising
Continued use of dexamethasone (more than 25 mg for 2 weeks) can lower the
function of the adrenal glands
Dexamethasone may also alter the body's defense system increasing the chance
of infections
Skin rashes with thalidomide are usually mild, but serious dermatologic reactions
including Stevens-Johnson Syndrome (a severe and sometimes fatal form of a
skin disease consisting of a rash or lesions and reddening or discoloration of the
skin that often results in blindness), which may be fatal, have been reported.
THALOMIDTM (thalidomide) should be stopped if a skin rash occurs and only
8/13/04
Page 10 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
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resumed after your doctor has checked your rash. If the rash causes the skin to
shed, become blotchy, or blister, or if Stevens-Johnson Syndrome or infectious
deadening of skin is suspected, use of thalidomide should not be resumed
Thalidomide may interact with certain drugs such as anti-seizure medications,
barbiturates, and alcohol. You must not take barbiturates or drink alcohol while
taking thalidomide. Use caution when driving or operating machinery
There may be a risk of added toxicity when dexamethasone is combined with
thalidomide
There is an increased risk of kidney damage when thalidomide is combined with
bisphosphonates (drugs commonly given as supportive care for myeloma)
Secondary Malignancies: A number of established chemotherapeutic drugs have an
inherent (basic) risk of causing secondary cancers and/or leukemias (cancer of the
white blood cells). Certain drugs in use today, not currently known to be associated
with this risk, may be shown at a later time to result in the development of these
secondary cancers and/or leukemias, which may not be reversible.
Reproductive Risks of CC-5013 and Thalidomide
You should not become pregnant or father a baby while on this study. You should not
breastfeed your baby while on this study. The following contraceptive methods are
mandatory. If you are a woman of childbearing potential, you must refrain from sexual
intercourse or employ two methods of contraception: one of which is highly effective
(IUD, birth control pills, tubal ligation or partner’s vasectomy) and another additional
method (condom, diaphragm or cervical cap). Women who have had a hysterectomy or
have been postmenopausal and have had no period for at least 24 consecutive months
do not have to use the described contraceptive measures.
7/06
Men must be informed and understand the risk of birth defects. If you are a man, you
must agree to use latex condoms every time you have sex with a woman while taking
lenalidomide and thalidomide and for 4 weeks after you stop taking the drug even if you
have had a successful vasectomy.
7/06
Thalidomide is known to be present in the semen of men treated with thalidomide (it is
currently unknown if CC-5013 is present in the semen of men taking CC-5013).
You must tell the doctor if you have sex with a woman without using a latex condom,
or if you think for any reason that your partner may be pregnant.
You must NOT be a sperm or blood donor while being treated with lenalidomide
or thalidomide.
8/13/04
Page 11 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
7/06
1/07
7/06
Women who are still having periods and can become pregnant must have a pregnancy
test conducted by the doctor before taking part in this study. If you are pregnant, you
cannot take CC-5013 or thalidomide. The pregnancy test is performed on blood drawn
from a vein 28 days prior to starting therapy and then another one within 24 hours
before the start of CC-5013 (lenalidomide) or thalidomide. You must have a pregnancy
test done by the doctor every week during the first 4 weeks of treatment. You will then
have a pregnancy test every 4 weeks if your periods are regular or every 2 weeks if
your cycles are not regular. You may also need to have a pregnancy test if you miss
your period or have unusual menstrual bleeding while on this study. If the pregnancy
test is positive, you will not be able to take part in the study. You will be told the results
of the pregnancy test.
You must not breast-feed a baby while being treated with lenalidomide. You must
NEVER donate blood or ova while being treated with lenalidomide. Lenalidomide does
not induce abortion of the fetus and should never be used for contraception.
Thalidomide causes severe birth defects in unborn babies if females who are pregnant
take it. The risk of thalidomide causing damage to the embryo is up to 50% for females
taking thalidomide during the “sensitive period,” which is estimated to range from 35-50
days after the last menstrual period. It is not known whether thalidomide may cause
birth defects in unborn babies if it is taken after the “sensitive’ period". A single dose of
thalidomide may cause birth defects. Because CC-5013 is a close relative of
thalidomide, similar risks may exist with this drug as well. In animal studies so far, there
have been no birth defects associated with CC-5013, but we are being cautious
because CC-5013 is chemically very similar to thalidomide.
Birth defects observed in babies exposed to thalidomide during pregnancy include
absent or abnormal legs and arms; spinal cord defects; cleft lip or palate; absent or
abnormal external ear; heart, kidney, and genital abnormalities; and abnormal formation
of the digestive system, including blockage of necessary openings. A 1994 article by
Stromland and others describes an association between thalidomide and autism.
Because of the severity of these abnormalities, it is extremely important that
pregnancies do not occur while you are taking CC-5013 or thalidomide.
You should discuss with your doctor what the best methods of birth control are for you.
Remember, however, that no method of birth control besides complete abstinence
provides 100% protection from pregnancy.
Patients with a history of infertility should still take the appropriate contraceptive
measures.
8/13/04
Page 12 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Important Information and Warnings for All Patients Taking CC-5013 or
Thalidomide
Warning: Serious Human Birth Defects
If CC-5013 or Thalidomide ARE taken during pregnancy, it can cause severe birth defects or
death to an unborn baby. CC-5013 and Thalidomide should never be used by women who
are pregnant or who could become pregnant while taking the drug. Even a single dose taken
by a pregnant woman can cause severe birth defects.
CONSENT FOR WOMEN:
INIT:
1. I understand I must not take CC-5013 or THALOMID™ (thalidomide) if I
am pregnant, breast-feeding a baby, or able to get pregnant and not using the required
two methods of birth control.
INIT:
2. I understand that severe birth defects can occur with the use of CC-5013
or THALOMID™ (thalidomide). I have been warned by my doctor that my unborn baby
will almost certainly have serious birth defects or may even die if I am pregnant or
become pregnant while taking CC-5013 or THALOMID™ (thalidomide).
INIT:
3. I understand that if I am able to become pregnant, I must use at least one
highly effective method and one additional effective method of birth control
(contraception) AT THE SAME TIME:
At least one highly effective method
AND
IUD
Hormonal (birth control pills, injections, or implants)
Tubal ligation
Partner’s vasectomy
One additional Method
Latex condom
Diaphragm
Cervical cap
These birth control methods must be used for at least 4 weeks before starting CC-5013
or THALOMID™ (thalidomide) therapy, all during CC-5013 or THALOMID™
(thalidomide) therapy, and for at least 4 weeks after CC-5013 or THALOMID™
(thalidomide) therapy has stopped. I must use these methods even if I am infertile,
unless I have had a hysterectomy or because I have been post-menopausal for at least
24 months (been through the changes of life). The only exception is if I completely
avoid heterosexual intercourse. If a hormonal (birth control pills, injections, or implants)
or IUD method is not medically possible for me, I may use another highly effective
method or two barrier methods AT THE SAME TIME.
INIT:
4. I know that I must have a pregnancy test done by my doctor within 28
days prior to registration, within the 24 hours prior to starting CC-5013 or THALOMID™
(thalidomide) therapy, then every week during the first 4 weeks of CC-5013 or
THALOMID™ (thalidomide) therapy. I will then have a pregnancy test every 4 weeks if I
8/13/04
Page 13 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
have regular menstrual cycles, or every 2 weeks if my cycles are irregular while I am
taking CC-5013 or THALOMID™ (thalidomide).
INIT:
5. I know that I must immediately stop taking CC-5013 or THALOMID™
(thalidomide) and inform my doctor if I become pregnant while taking the drug; if I miss
my menstrual period, or experience unusual bleeding; stop using birth control; or think,
FOR ANY REASON, that I may be pregnant. If my doctor is not available, I can call 1888-668-2528 for information on emergency contraception.
INIT:
6. I am not now pregnant, nor will I try to become pregnant for at least 4
weeks after I have completely finished taking CC-5013 or THALOMID™ (thalidomide).
INIT:
7. I understand that CC-5013 or THALOMID™ (thalidomide) will be
prescribed ONLY for me. I must NOT share it with ANYONE, even someone who has
symptoms similar to mine. It must be kept out of the reach of children and should never
be given to women who are able to have children.
INIT:
8. I understand CC-5013 or THALOMID™ (thalidomide) can cause side
effects including nerve damage (numbness, tingling or pain in the hands of feet that
may not be reversible) and drowsiness. (If I become drowsy, I will not operate heavy
machinery or drive a car. Also, I will avoid alcohol and other medicines not prescribed
by my doctor). If I develop a red itchy rash I will contact my doctor immediately. If I feel
dizzy, I will sit upright for a few minutes before standing up from a lying or sitting
position. I understand all of the other possible side effects explained to me by my
doctor. I know that I cannot donate blood while taking CC-5013 or THALOMID™
(thalidomide).
INIT:
9. My doctor has answered any questions I have asked.
CONSENT FOR MEN:
INIT:
1. I understand that I must not take CC-5013 or THALOMID™ (thalidomide)
if I cannot avoid unprotected sex with a woman, even if I have had a successful
vasectomy.
INIT:
2. I understand that severe birth defects or death to an unborn baby have
occurred when women took thalidomide during pregnancy.
INIT:
3. My doctor has told me that I must NEVER have unprotected sex with a
woman because it is not known if the drug is present in semen or sperm. My doctor has
explained that I must either completely avoid heterosexual sexual intercourse or I must
use a latex condom EVERY TIME I have sexual intercourse with a female partner while
I am taking CC-5013 or THALOMID™ (thalidomide) - and for 4 weeks after I stop taking
the drug, even if I have had a successful vasectomy.
INIT:
4. I also know that I must inform my doctor if I have had unprotected sex with
a woman; or if I think, FOR ANY REASON, that my sexual partner may be pregnant. If
my doctor is not available, I can call 1-888-668-2528 for information on emergency
contraception.
8/13/04
Page 14 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
INIT:
5. I understand that CC-5013 or THALOMID™ (thalidomide) will be
prescribed ONLY for me. I must NOT share it with ANYONE, even someone who has
symptoms similar to mine. It must be kept out of the reach of children and should never
be given to women who are unable to have children.
INIT:
6. I understand CC-5013 or THALOMID™ (thalidomide) can cause side
effects including nerve damage (numbness, tingling or pain in the hands of feet that
may not be reversible) and drowsiness. (If I become drowsy, I will not operate heavy
machinery or drive a car. Also, I will avoid alcohol and other medicines not prescribed
by my doctor). If I develop a red itchy rash I will contact my doctor immediately. If I feel
dizzy, I will sit upright for a few minutes before standing up from a lying or sitting
position. I understand all of the other possible side effects explained to me by my
doctor. I know that I cannot donate blood while taking CC-5013 or THALOMID™
(thalidomide).
INIT:
7. My doctor has answered any questions I have asked.
Authorization:
In the Signatures section of this form, you will be asked to verify that this information
has been read aloud to you, that you understand that if you do not follow all of your
doctor’s instructions you will not receive CC-5013 or thalidomide, and that you authorize
your doctor to begin treatment with CC-5013 or thalidomide.
1/07
1/07
Risks of supportive care therapy
As part of standard supportive care for myeloma you will most likely be receiving drugs
such as pamidronate or zoledronic acid to strengthen your bones. There may be an
increased risk of kidney problems when these drugs are used along with thalidomide or
CC-5013. You will be monitored for kidney problems before each pamidronate or
zoledronic acid treatment you receive. Also the main risks of aspirin and the blood
thinner coumadin are bleeding complications which can be serious or life-threatening.
The risk of bleeding complications may be greater in patients receiving coumadin
compared to aspirin.
Risks of Bone Marrow Tests:
There may be infection, bleeding or bruising at the site of the bone marrow biopsy or
aspiration, as well as possible inflammation of the vein or infection. A bone marrow
aspiration is a procedure in which an area of the hip is numbed and a small sample of
bone marrow fluid is withdrawn. A bone marrow biopsy is similar except a sample of
bone marrow tissue is removed through the needle. There may be temporary pain or
discomfort at the bone marrow site. However, a local anesthetic is routinely used to
numb the skin, and care will be taken to avoid these complications. Bone marrow
studies carry very minimal risk to the patient.
8/13/04
Page 15 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Are There Benefits to Taking Part in the Study?
If you agree to take part in this study, there may or may not be direct medical benefit to
you.
Possible benefits include improvement in the symptoms related to your cancer, and
prolonged survival.
We hope the information learned from this study will benefit other patients' myeloma in
the future.
What Other Options Are There?
Instead of being in this study, you have these options:
 Chemotherapy with vincristine, adriamycin and dexamethasone
 Chemotherapy with melphalan and prednisone
 Therapy with dexamethasone alone
 Therapy with thalidomide plus dexamethasone
 Comfort care only, where treatments are directed only at reducing symptoms,
relieving suffering, and maximizing comfort, dignity, and control. In comfort care
only, treatment is not directed at curing, slowing or reversing your disease.
Please talk to your doctor about these and other options.
Will my medical information be kept private?
This study is being conducted by the Eastern Cooperative Oncology Group (ECOG).
ECOG is a cancer group that conducts studies for the National Cancer Institute. To
help protect your privacy, ECOG has obtained a Confidentiality Certificate from the
Department of Health and Human Services (DHHS).
With this Certificate, ECOG cannot be forced (for example, by court subpoena) to
disclose information that may identify you in any federal, state, or local civil, criminal,
administrative, legislative or other proceedings. Disclosure will be necessary, however,
upon request of the Department of Health and Human Services for audit or program
evaluation purposes.
You should understand that a Confidentiality Certificate does not prevent you or a
member of your family from voluntarily releasing information about yourself or your
involvement in this research. Note however, that if an insurer or employer, learns about
your participation, and obtains your consent to receive research information, then
ECOG may not use the Certificate of Confidentiality to withhold this information. This
means that you and your family must also actively protect your own privacy.
Finally, you should understand that your doctor and ECOG are not prevented from
taking steps, including reporting to authorities, to prevent serious harm to yourself or
8/13/04
Page 16 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
others, and the Certificate does not prevent the review of your research records under
some circumstances by certain organizations for an internal program audit or
evaluation. If information from this study is published or presented at scientific
meetings, your name and other personal information will not be used.
A record of your progress will be kept in a confidential form at your hospital or doctor’s
office where you receive treatment. Organizations that may inspect and/or copy your
research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance, research, and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Cancer Trials Support Unit (CTSU) and its representatives
Eastern Cooperative Oncology Group (ECOG)
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
A qualified representative of applicable drug manufacturers, distributors, and/or
their representatives
Other regulatory agencies and/or their designated representatives
Designated laboratories and reviewers
If your record is used or given out for governmental purposes, it will be done under
conditions that will protect your privacy to the fullest extent possible consistent with laws
relating to public disclosure of information and law-enforcement responsibilities of the
agency. These agencies may review the research to see that it is being done safely
and correctly.
You authorize the use of clinical information contained in your records, but any
publication which includes such information or data shall not reveal your name, show
your picture or contain any other personally identifying information, except as otherwise
required by law.
1/07
3/06
What are the costs of taking part in this study?
The Division of Cancer Treatment, and Diagnosis, NCI will provide you with the NCI
sponsored/supplied agents (CC-5013 for Groups A, B, S and T, thalidomide if you need
to register to Groups C or D) free of charge for this study. If you respond well to
CC-5013 treatment, CC-5013 may be provided until your myeloma shows signs of
worsening. If you do not respond well to CC-5013, but do respond well to thalidomide,
3/06
thalidomide will be provided until your myeloma shows signs of worsening.
Every effort will be made to ensure adequate supplies of the sponsored/supplied
agents, free of charge, for all participants. If the drug becomes commercially available
for this indication there is a remote possibility that you may be asked to purchase
subsequent supplies. Your doctor will discuss this with you should this situation arise.
8/13/04
Page 17 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
3/06
The aspirin which is used to prevent blood clots is available over the counter, and will
be paid for by you. If your doctor prescribes alternate medications, they will be billed to
your insurance. Please discuss this with your doctor.
You and/or your health plan/insurance provider (Medicare should be considered a
health insurance provider) will need to pay for some or all of the costs of treating your
cancer in this study. Some health plans will not pay these costs for people taking part in
studies. Check with your health plan or insurance company to find out what they will
pay for. Taking part in this study may or may not cost your insurance company more
than the cost of getting regular cancer treatment. You or your insurance carrier will be
responsible for the costs of clinic visits, any hospital admissions, laboratory tests, xrays, scans, chemotherapy treatments, radiation treatments, and any other tests.
Please ask your doctor about any added costs or insurance problems.
In the case of injury or illness resulting from this study, emergency medical treatment is
available but will be provided at the usual charge. No funds have been set aside to
compensate you in the event of injury.
7/06
What are my rights if I take part in this study?
Even after you agree to take part in this study, you may withdraw at any time. Before
you withdraw, you should talk to one of the researchers or nurses involved. This will
allow them to inform you of any medical problems that could result from stopping your
treatment. You can choose to withdraw one of two ways. In the first, you can stop your
study treatment, but still allow the study doctor to follow your care. In the second, you
can stop your study treatment and not have any further contact with the study staff.
Either way, there will be no penalty to you. Your decision will not affect your medical
treatment or your relationship with those treating you or with this institution. If you
withdraw from the study, you will still be offered all available care that suits your needs
and medical condition. You are free to seek care from a doctor of your choice at any
time.
Taking part in this study is voluntary. You may choose not to take part or may leave the
study at any time. Leaving the study, or choosing not to take part, will not result in any
penalty or loss of benefits to which you are entitled.
A Data Safety and Monitoring Board, an independent group of experts, will be reviewing
the data from this research throughout the study. We will tell you about the new
information from this or other studies that may affect your health, welfare, or willingness
to stay in this study.
Additional specimen collection (not for diagnostic purposes) will not occur until you have
consented for the study.
8/13/04
Page 18 of 24
Participant Initials _____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Who can answer my questions about the study?
For questions about the study or a research-related injury, contact your doctor,
_________________, at # _____________________. You may ask your doctor for
further information on the risks, benefits or alternative treatments.
For questions about your rights as a research participant, contact the
___________________ Institutional Review Board (which is a group of people at the
hospital in the community where you receive treatment who review the research to
protect your rights) at # ____________________ (the office of ___________________).
You may also call the Operations Office of the NCI Central Institutional Review Board
[CIRB] at 888-657-3711 [from the continental U.S. only].
Where can I get more information?
 You may call the National Cancer Institute’s (NCI’s) Cancer Information Service
at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615



You may also visit the NCI Web site at http://cancer.gov
For the NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials
For the NCI’s general information about cancer, go to:
http://cancer.gov/cancerinfo

Cancer Fax includes NCI information about cancer treatment, screening,
prevention, and supportive care. To obtain a contents list, dial 301-402-5874 or
800-624-2511 from a fax machine hand set and follow the recorded instructions.
Participant Contract
I have been offered the opportunity to ask questions about this study and all questions
have been answered to my satisfaction. The contents of this form have been explained
to me and I understand them. I agree to allow the research personnel specified above
the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new
information about the treatment I received; therefore I agree to notify my doctor of any
change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research
study. I will be given a copy of all 24 pages of this consent. I may also request a copy of
the study (complete study plan).
8/13/04
Page 19 of 24
Participant Initials ____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Information about thalidomide and CC-5013 has been read aloud to me in the language
of my choice. I understand that if I do not follow all of my doctor’s instructions, I will not
be able to receive CC-5013 or THALOMID™ (thalidomide). I now authorize my doctor
to begin my treatment with CC-5013 or THALOMID™ (thalidomide).
______________
(Date)
_________________________________
(Participant Signature)
I have fully explained to the patient the nature, purpose, and risks of the treatment
described above, especially the risks to women of childbearing potential. I have asked
the patient if she/he has any questions regarding her/his treatment with CC-5013 or
THALOMID™ (thalidomide) and have answered those questions to the best of my
ability. I will ensure that the appropriate components of the patient consent form are
completed.
______________
(Date)
_________________________________
(Signature of Person Obtaining Consent)
Scientific Laboratory Studies
This study includes laboratory test(s) that will analyze a small sample of blood and bone
marrow. These samples will be collected before you start treatment and when you
discontinue the treatment on any of the treatment Groups of the trial. The blood
samples will be collected using a needle to draw some blood out of a vein. The bone
marrow samples, as far as possible, will be obtained at the time of the bone marrow
biopsies scheduled for the treatment aspect of this study. No additional biopsies will be
done to obtain this material. The blood and bone marrow will be sent to a laboratory
where tests will be performed. Researchers will be performing these tests in order to
understand how your treatment procedures attack your cancer cells. They hope this will
help them better understand your type of cancer. The results from these tests will not
be sent to you or your doctor, and will not be used in planning your care. Neither you or
your insurance company will be billed for these tests. These tests are only for research
purposes.
Making Your Choice
Please read the sentence below and think about your choice. After reading the
sentence, circle "Yes" or "No." No matter what you decide to do, it will not affect your
care. You can participate in the treatment part of the study without participating in the
scientific laboratory studies. If you have any questions, please talk to your doctor or
nurse, or call our research review board at phone # ___________________ .
8/13/04
Page 20 of 24
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
I agree to participate in the scientific laboratory studies that are being done as a part of
this study.
Yes
No
Please print and sign your name here after you circle your answer.
Your Name:
Your Signature:
Date:_____________
Will Any of the Samples (Blood and Bone Marrow) Taken from Me Be Used for
Other Research Studies?
About Using Tissue for Research
If you agree to participate in the laboratory studies, samples of your blood and bone
marrow will be sent to a central laboratory for tests.
We would like to keep some of the blood and bone marrow that is left over for future
research. If you agree, this blood and bone marrow will be kept and may be used in
research to learn more about cancer and other diseases. This blood and bone marrow
will only be given to researchers approved by the Eastern Cooperative Oncology Group.
Any research done on the tissue must also be approved by the researcher's Institutional
Review Board.
The research that may be done with your blood and bone marrow will probably not help
you. It might help people who have cancer and other diseases in the future.
Reports about research done with your blood and bone marrow will not be given to you
or your doctor. These reports will not be put in your health record. The research will
not have an effect on your care.
Things to Think About
The choice to let us keep the left over blood and bone marrow for future research is up
to you. No matter what you decide to do, it will not affect your care and you may still
take part in this Eastern Cooperative Oncology Group study.
If you decide now that your blood and bone marrow can be kept for research, you can
change your mind at any time. Just contact your study doctor and let him or her know
that you do not want us to use your blood and bone marrow. Then the blood and bone
marrow will no longer be used for research.
In the future, people who do research may need to know more about your health. When
the Eastern Cooperative Oncology Group gives them reports about your health, it will
not give them your name.
8/13/04
Page 21 of 24
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Sometimes your blood and bone marrow is used for genetic research (about diseases
that are passed on in families). Even if your blood and bone marrow is used for this
kind of research, the results will not be put in your health records.
Your blood and bone marrow will be used only for research and will not be sold. You
will not be paid for allowing your leftover blood and bone marrow to be used in research
even though the research done with your blood and bone marrow may help to develop
new products in the future. Similarly there will be no cost to you for any blood and bone
marrow collected and stored by the Eastern Cooperative Oncology Group.
Benefits
The benefits of research using your blood and bone marrow include learning more
about what causes cancer and other diseases, how to prevent them, how to treat them,
and how to cure them.
Risks
There are very few risks to you when your blood and bone marrow are stored or used in
any future laboratory studies. The greatest risk is the release of information from your
health records. The Eastern Cooperative Oncology Group will protect your records so
that your name will be kept private. The chance that this information will be given to
someone else is very small.
Making Your Choice
Please read each sentence below and think about your choice. After reading each
sentence, circle "Yes" or "No." No matter what you decide to do, it will not affect your
care. You can participate in the treatment part of the study without participating in all or
part of the blood or bone marrow research studies. If you have any questions, please
talk to your doctor or nurse, or call our research review board at IRB's phone number
1.
My blood and bone marrow may be kept for use in research to learn
about, prevent, treat, or cure cancer.
Yes
No
2.
My blood and bone marrow may be kept for research about other health
problems (for example: causes of diabetes, Alzheimer's disease, and
heart disease).
Yes
No
3.
My doctor (or someone from the Eastern Cooperative Oncology Group )
may contact me in the future to ask me to take part in more research.
Yes
No
Please print and sign your name here after you circle your answers.
Your Name: __________________________________________________________
Your Signature: _______________________________
Date: _______________
8/13/04
Page 22 of 24
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Study Plan
Step 1
You will be randomly assigned to Groups A or B, and receive CC-5013 and
dexamethasone.
1/07
If you start treatment after December of 2006, instead of Groups A or B, you will
be randomly assigned to Group S or T, and receive CC-5013 and standard dose
dexamethasone plus coumadin or aspirin.
1/07
Group A, S, T: You will take 25 mg/day of CC-5013 on days 1-21 of each 28-day
cycle. You will also take 40 mg/day of dexamethasone, on days 1-4, 9-12 and 1720 of each cycle.
Group B: You will take 25 mg/day of CC-5013 on days 1-21 of each 28-day cycle.
You will also take 40 mg/day of dexamethasone, on days 1, 8, 15 and 22 of each
cycle.

If your myeloma gets worse while on Group A or Group B, you will have 2 options
at time of progression (your treatment will be up to you and your physician):
1. register to Step 2 (Group C or D), or
2. end protocol treatment.
1/07
●
●
1/07
3/06
3/06
1/07

1/05, 1/07
1/07
●
If your melanoma gets worse while on Group S or T, you will end protocol
treatment.
If your myeloma responds well to treatment at any time during the first 4 cycles of
treatment on Group A,B, S, or T, you will have 2 options after the end of 4 cycles:
1. end protocol treatment and proceed to alternate therapy, such as stem cell
transplant, or
2. continue protocol treatment until your myeloma shows signs of worsening
(CTEP will continue to provide you with CC-5013 free of charge during this
time. If your disease gets worse at any point, you will stop taking the
drug and you will discuss future treatment with your doctor).
If your myeloma neither responds well nor gets worse at any time during the first
4 cycles of treatment on Group A or B, you may register to Step 2 after the end of
4 cycles. Note that patients who experienced side effects while on CC-5013
which might be expected to get worse if treated with thalidomide will not register
to Step 2, and will end treatment instead.
If your myeloma neither responds well nor gets worse at any time during
the first 4 cycles of treatment on Group S or Group T, you will end protocol
treatment after 4 cycles.
8/13/04
Page 23 of 24
Participant Initials ____
IRB Approval Date __________
Version: 10/24/06; Addend. #6
Broadcast: 1/27/07
CTSU/ECOG E4A03
Southeast Cancer Control Consortium Consent Form
Step 2
Patients previously on Groups A and B, who meet the requirements for Step 2
entry described above register to Groups C and D, respectively.
Group C: You will take 200 mg/day of thalidomide on days 1-28 of each 28day cycle. You will also take 40 mg/day of dexamethasone, on days 1-4, 912 and 17-20 of each cycle.
Group D: You will take 200 mg/day of thalidomide on days 1-28 of each 28day cycle. You will also take 40 mg/day of dexamethasone, on days 1, 8, 15
and 22 of each cycle.
1/05

If your myeloma gets worse while on Step 2 (Groups C or D), you will end
protocol treatment immediately and your future treatment options will be
explained by your doctor.

If your myeloma responds well to treatment at any time during the first 4 cycles of
Step 2 treatment have 2 options after the end of 4 cycles:
3/06
3/06
1/07

1. end protocol treatment and proceed to alternate therapy, such as stem cell
transplant, or
2. continue protocol treatment until your myeloma shows signs of worsening
(CTEP will continue to provide you with thalidomide free of charge during
this time. If your disease gets worse at any point, you will stop taking
the drug and you will discuss future treatment options with your doctor).
If your myeloma neither responds well nor gets worse at any time during the first
4 cycles of treatment, you will stop receiving thalidomide after the 4 cycles are
finished, and discuss future treatment options with your doctor.
Southeast Cancer Control Consortium Withdrawal of Consent
8/13/04
Page 24 of 24
Participant Initials ____
CTSU/ECOG E4A03
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Participant Name ___________________________________ Study/ID #___________
(Please Print Name)
Participant Signature ____________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
8/13/04
CTSU/ECOG E4A03
I, _____________________________, withdraw my consent for treatment on this study.
Even though I withdraw my consent for treatment, I will continue to be followed and
clinical data will be collected from my medical records.
Participant Name ___________________________________Study/ID #____________
(Please Print Name)
Participant Signature ____________________________________
Date __________
Witness Signature ______________________________________
Date __________
8/13/04