Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Eastern Cooperative Oncology Group
Document related concepts
no text concepts found
Transcript
IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide Versus Melphalan, Prednisone and Lenalidomide in Newly Diagnosed Myeloma Patients Who Are Not Candidates for High-Dose Therapy What is a research study? This is a clinical trial, a type of research study. Your doctor will explain the clinical trial to you. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your doctor for more explanation. You are being asked to take part in this study because you have been diagnosed with multiple myeloma. Why is this study being done? Melphalan and prednisone remains the backbone of treatment for patients with myeloma who are 65 years of age or older. Recently adding the drug Thalidomide to this combination has been shown to improve both the chance of response to treatment and survival for patients but at the cost of added side effects. Lenalidomide is a drug related to Thalidomide and has now been shown to also be highly effective when used with Melphalan and prednisone. Although this new combination appears promising and may have fewer side effects, it is not yet known if it is as good as, better than, or less helpful than Melphalan, prednisone and Thalidomide. The purpose of this study is then to compare the effects, good and/or bad, of Lenalidomide added to Melphalan and prednisone with those of Thalidomide, Melphalan and prednisone on you and your newly diagnosed multiple myeloma to find out which is better. In this study, you will get either Lenalidomide added to Melphalan and prednisone or Thalidomide added to Melphalan and prednisone. You will not get both Lenalidomide and Thalidomide. In younger patients (less than age 65), Melphalan given in high doses with blood stem cell transplant support is thought to prolong survival. This may be an option for you that you should discuss with your doctor. If you are not a candidate for or choose not to have a blood stem cell transplant, then the study explained here might be an option for you. Please be aware that treatment with Melphalan as part of this study may make it impossible to harvest blood stem cells to be used in a blood stem cell transplant in the future. You should therefore talk to your doctor about blood stem cell transplants before you decide to take part in this study. You may become physically ineligible for bone marrow transplant as a result of your treatment with Melphalan, regardless of any prior harvest of blood stem cells. 9/24/08 Melphalan, prednisone and Thalidomide have been approved by the FDA for use in multiple myeloma. The combination of these drugs is now considered to be the standard of care for patients with myeloma. Lenalidomide is approved by the FDA for treating relapsed myeloma patients, but has not yet been approved for use in newly diagnosed patients. 2/29/08 Page 1 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form 10/13/10 9/16/09 9/16/09 9/24/08 9/24/08 9/24/08 9/16/09 9/24/08 9/24/08 9/24/08 9/16/09 How many people will take part in the study? About 304 people will take part in this study. Half of the patients will receive Lenalidomide, Melphalan and prednisone, and the other half will receive Thalidomide, Melphalan and prednisone. You will be randomly assigned (like flipping a coin) to one of the two treatment groups. What will happen if I take part in this research study? To be eligible to participate, you must not have received prior treatment for your myeloma except for a short (4 weeks or less) treatment with either prednisone or dexamethasone with or without 2 weeks or less of either Thalidomide or Lenalidomide. This study is for patients who are not good candidates for blood stem cell transplants, or who have decided not to have a transplant. Please be aware that treatment with Melphalan as part of this study may make it impossible to harvest blood stem cells for a blood stem cell transplant in the future. You may become physically ineligible for bone marrow transplant as a result of your treatment with Melphalan, regardless of any prior harvest of blood stem cells. Please talk to your doctor about blood stem cell transplants before you decide to take part in this study. Once registered you will be assigned to receive one of two treatments, Group A or Group B. Group A If you are assigned to Group A, you will receive 12 cycles (1 cycle = 28 days) of treatment. On days 1-4, of each cycle you will receive 9 mg/m2 of Melphalan and 100 mg of prednisone by mouth. On each day of the cycle you will take 100 mg of Thalidomide by mouth. You will take 325 mg of enteric coated aspirin by mouth every day of each cycle of treatment. This is to prevent a side effect (blood clotting, which could be serious) associated with the drug Thalidomide. Your doctor may choose to use other drugs to prevent clotting instead of enteric coated aspirin if he feels you are at high risk for blood clots. At the end of 12 cycles you will stop melphalan and prednisone, but stay on Thalidomide and enteric coated aspirin until your disease comes back or you have side effects that make stopping the drug in your best interest. This part of the treatment is called maintenance treatment. Each cycle of maintenance treatment = 28 days. Group B If you are assigned to Group B, you will receive 12 cycles (1 cycle = 28 days) of treatment. On days 1-4 of each cycle you will receive 5 mg/m2 of Melphalan and 100 mg of prednisone by mouth. On day 1-21 of each cycle of treatment you will take 10 mg of Lenalidomide by mouth. You will take 325 mg of enteric coated aspirin by mouth every day. This is to prevent a side effect (blood clotting, which could be serious) associated with the drug Lenalidomide. Your doctor may choose to use other drugs to prevent clotting instead of enteric coated aspirin if he feels you are at high risk for blood clots. At the end of 12 cycles you will stop melphalan and prednisone, but stay on lenalidomide (day 1-21) and enteric coated aspirin (days 1-28) until your disease comes back or you have side effects that make stopping the drug in your best interest. This 2/29/08 Page 2 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form part of the treatment is called maintenance treatment. Each cycle of maintenance treatment = 28 days. Quality of Life You will be asked to complete questionnaires to assess your well being during and after the study. This includes how you were affected by side affects associated with treatments you will receive. There are 39 questions in all. We expect it will take about 30 minutes to answer these questions. Times: Before Cycle 1 (induction) Before Cycle 7 (induction) After Cycle 12 (maintenance) After Cycle 18 (maintenance) After Cycle 24 (maintenance) After Cycle 38 (maintenance) If your disease gets worse before cycle 38, you will be asked to answer the questions at that time, and to do the next available follow-up questionnaire. Risks: Completing the questionnaires which are part of this study may remind you of unpleasant aspects of your condition and treatment, which may be upsetting. Hospitalization You will not need to be hospitalized to take part in this study unless you experience a serious side effect. Before you begin the study You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your doctor. A general exam will be done to ensure your overall health Tubes of blood will be drawn to test your general health and well being. These tests will check your blood counts, liver and kidney functions, and confirm diagnosis. A sample of bone marrow aspirate will be taken You will be asked to provide urine samples You will need to have a bone survey If you are a female who could become pregnant, you will need to have two pregnancy tests, one will be 10-14 days before treatment, and the other will be no more than 24 hours before the start of treatment. 2/29/08 Page 3 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form During the study If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care. A general exam will be done to ensure your overall health. Tubes of your blood will be taken to test your general health and well being, including blood counts, and liver and kidney function tests. This will be completed on day 1 of each cycle. Bone marrow aspirate samples will be taken if your doctor thinks the myeloma has gone away completely and needs to confirm that and after 12 cycles of treatment. An ultrasound of your legs may be done if you have any pain or swelling. You will need these tests and procedures that are part of regular cancer care. They are being done more often because you are in this study, to see how the study drugs are affecting your body. Blood and urine tests Patient Diary Your doctor 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. When I am finished taking the study drugs A general exam will be done to ensure your overall health. Tubes of your blood will be taken to test your general health and well being, including blood counts, and liver and kidney function tests. This will be completed every 3 months after therapy has been completed up to two years from the day of randomization, every 6 months in years 2-5 after randomization, and every 12 months in years 6-10 after randomization, until you experience progressive disease. Bone marrow aspirate samples will be taken every 12 months after the end of treatment. 2/29/08 Page 4 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Study Chart You will receive 3 drugs at multiple timepoints during each cycle in this study. A cycle is defined as 28 days. The cycle will be repeated a total of 12 times. Each cycle is numbered in order. The chart below shows what will happen to you during Cycle 1 and future treatment cycles as explained previously. The left-hand column shows the day in the cycle and the right-hand column tells you what to do on that day. Cycle 1(9/24/08) Day What you do Within 28 days of starting study Day before starting study Day 1, 2, 3 and 4 Days 5-21 if receiving Lenalidomide (Group B) Days 5-28 if receiving Thalidomide (Group A) Day 22-28 if receiving Lenalidomide (Group B) Get routine blood work and exams Get routine blood work, if needed Receive Melphalan, prednisone, enteric coated aspirin and either Thalidomide or Lenalidomide (9/24/08) Receive Lenalidomide and enteric coated aspirin(9/24/08) Receive Thalidomide and enteric coated aspirin(9/24/08) Enteric coated aspirin only on these days(9/24/08) Cycles 2-12 Day Days 1-27 Day 28 2/29/08 What You Do Keep following the regimen if you have no bad side effects and myeloma is not getting worse. Call the doctor at _____________ [insert phone number] if you do not know what to do Get routine blood tests day 1 of each cycle (more if your doctor tells you to). Return to your doctor’s office at _______ [insert appointment time] for your next exam and to begin the next cycle Page 5 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Study Plan Another way to find out what will happen to you during the study is to read the chart below. Start reading at the left and read across the list. You will be randomized into one of two groups, called Group A and Group B. Group B Group A 12 Cycles (1 cycle = 28 days) 12 Cycles (1 cycle = 28 days) 9 mg/m2 daily for 4 days by mouth, every 28 days Prednisone 100 mg daily for 4 days by mouth, every 28 days Thalidomide 100 mg daily continuously by mouth Enteric coated aspirin 325 mg daily continuously by mouth (9/24/08) Melphalan Melphalan Prednisone Lenalidomide Enteric coated aspirin (9/24/08) Maintenance 5 mg/m2 daily for 4 days by mouth, every 28 days 100 mg daily for 4 days by mouth, every 28 days 10 mg days 1-21 of a 28 day cycle continuously by mouth 325 mg daily continuously by mouth Maintenance Thalidomide 100 mg by mouth, daily, continuously Lenlidomide 10 mg by mouth, daily for 21 days, every 28 days Enteric coated aspirin 325mg daily continuously by mouth(9/24/08) Enteric coated aspirin 325mg daily continuously by mouth(9/24/08) Each cycle = 28 days Each cycle = 28 days 2/29/08 Page 6 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form How long will I be in the study? You will be asked to take the treatment you are assigned to, until one of the following happens: Your disease gets worse 2. You no longer want to continue with treatment 3. You begin another treatment 4. You experience serious side-effects 1. After you have finished your designated regimen, the doctor will ask you to visit the office for follow-up exams for at least 10 years. Can I stop being in the study? Yes. You can decide to stop at any time. Tell the doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. It is important to tell the doctor if you are thinking about stopping so any risks from discontinuing the Melphalan, prednisone, Thalidomide, and/or Lenalidomide can be evaluated by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you. The doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped. What side effects or risks can I expect from being in the study? You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don’t know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking the medications. In some cases, side effects can be serious, long lasting, or may never go away. There also may be a risk of death. You should talk to your doctor about any side effects that you have while taking part in the study. Risks and side effects related to Thalidomide Include: Likely: (Updated 9/3/09) ● Constipation ● Sleepiness ● Birth Defects 2/29/08 Page 7 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Less Likely: (Updated 9/3/09 and 7/21/10) Slow heartbeat with a regular rhythm Abnormally low level of thyroid gland hormone Blurred vision Dry eye Diarrhea Dry mouth Heartburn Nausea or the urge to vomit Swelling of the extremities (arms and/or legs) Fatigue or tiredness Fever Decreased number of a type of white blood cell (or neutrophil or granulocyte) Decrease in the total number of white blood cells (or leukocytes) Muscle weakness of the whole body Muscle pain Loss of muscle coordination: This can be awkward, uncoordinated walking or unsteadiness when walking. Dizziness or sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking Headache or head pain Weakness or paralysis (loss of muscle function) caused by damage to peripheral nerves (those nerves outside of brain and spinal cord) Inflammation (or swelling and redness) or degeneration of the peripheral nerves (those nerves outside of brain and spinal cord) causing numbness, tingling, and burning Convulsion or seizure Uncontrolled trembling or shaking movements in one or more parts of your body Confusion Feelings of sadness, worthlessness, thoughts of suicide or death (also called depression) Shortness of breath Dry skin Severe reaction of the skin and gut lining that may include rash and shedding or death of tissue Itching Skin rash with the presence of macules (or flat discolored areas) and papules (or raised bumps) Low blood pressure Poor blood supply to extremities (arms and/or legs) Formation of a blood clot that breaks loose and is carried by the blood stream to plug another blood vessel 2/29/08 Page 8 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form 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. Reproductive Risks of Thalidomide 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. 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 Thalidomide. The drug is known to be present in male ejaculate (semen) of men treated with Thalidomide. 9/24/08 You must not breast-feed a baby while being treated with thalidomide. You must NEVER donate blood or ova while being treated with thalidomide. Thalidomide does not induce abortion of the fetus and should never be used for contraception. 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. Because Thalidomide is known to cause severe harm to an unborn baby, you should not become pregnant or father a baby while on this study or during the maintenance. You should not nurse your baby while on this study. The following contraceptive methods are mandatory. Women who could become pregnant must not have sexual intercourse or must use 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). All men should use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman who could become pregnant, while taking the drug and for 4 weeks after stopping treatment. Women who are still having periods and can become pregnant must have a pregnancy test before taking part in this study. The pregnancy test is done by a needle stick in your vein within 24 hours of receiving Thalidomide. 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. 2/29/08 Page 9 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form 7/1/11 Women having any chance of becoming pregnant must have a pregnancy test (sensitivity of at least 25 mIU/mL) performed. The test should be performed within 24 hours of beginning Thalidomide, weekly for the first 4 weeks of treatment, and then every 4 weeks if the patient's periods are regular or every 2 weeks if they are not. 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. Patients with a history of infertility should still take the appropriate contraceptive measures. These risks will be discussed each time you begin a new course of Thalidomide. Risks and side effects related to lenalidomide include: Likely: (Updated 11/13/08, 1/14/10, 3/17/10, and 10/4/11) Lack of enough red blood cells (called anemia) Constipation Diarrhea Fatigue or tiredness Decreased number of a type of white blood cell (called neutrophil or granulocyte) Decreased number of a type of blood cell that helps to clot blood (called platelet) Less Likely: (Updated 11/13/08, 1/14/10, 3/17/10, and 10/4/11) Abnormally low level of thyroid gland hormone Nausea or the urge to vomit Vomiting Chills Swelling of the arms and/or legs Fever Infection Decreased number of a type of white blood cell (called lymphocyte) Weight loss Decrease in the total number of white blood cells (called leukocytes) Loss of appetite Joint pain Back pain Muscle cramps or spasms Muscle pain Dizziness, sensation of lightheadedness, unsteadiness or giddiness Headache or head pain Difficulty sleeping or falling asleep Cough Shortness of breath Excess sweating Itching 2/29/08 Page 10 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Skin rash with the presence of macules (or flat discolored areas) and papules (or raised bumps) A chronic, inflammatory skin condition with sores covering the skin Formation of a blood clot that plugs the blood vessel: Blood clots may break loose and travel to another place, such as the lung. Rare, but Serious: (Updated 1/14/10, 3/17/10, and 10/4/11) Inflammation (or swelling and redness) of the pancreas Serious, life-threatening allergic reaction requiring immediate medical treatment by your doctor. The reaction may include extremely low blood pressure, swelling of the throat, difficulty breathing, and loss of consciousness. Increased blood level of fat-digesting enzyme (called lipase) Group of signs and symptoms due to rapid breakdown of tumor that can occur after treatment of cancer has started that causes increased levels of blood potassium, uric acid, and phosphate, decreased levels of blood calcium, and kidney failure A blood disease (called leukemia) caused by chemotherapy Decreased production of blood cells by the bone marrow Temporary growth in tumor or worsening of tumor related problems Development of a new cancer resulting from treatment of an earlier cancer Progressive necrosis (or tissue death) of a part (called the white matter) of the brain without inflammation (or swelling and redness) Sudden decrease of kidney function Severe reaction of the skin and gut lining that may include rash and shedding or death of tissue Potentially life-threatening condition affecting less than 10% of the skin in which cell death causes the epidermis (or outer layer) to separate from the dermis (or middle layer) Life-threatening condition affecting greater than 30% of the skin in which cell death causes the epidermis (or outer layer) to separate from the dermis (or middle layer) Reproductive Risks of Lenalidomide You should not become pregnant or father a baby while on this study or during maintenance. 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. 2/29/08 Page 11 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form 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 is a similar drug to Lenalidomide and has been shown to cause severe birth defects in the unborn babies of females who have taken it while pregnant. 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 Lenalidomide is a close relative of Thalidomide, similar risks may exist. 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. Also, a 1994 article by Stromland and others describe 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 Lenalidomide. The drug is known to be present in male ejaculate (semen) of men treated with 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. 7/1/11 Women having any chance of becoming pregnant must have a pregnancy test (sensitivity of at least 25 mIU/mL) performed within 10 to 14 days at beginning therapy and within 24 hours of beginning treatment. Women of childbearing potential on both Groups will repeat pregnancy tests weekly for the first 4 weeks of treatment, and then every 4 weeks if the patient’s periods are regular or every 2 weeks if they are not. 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. Patients with a history of infertility should still take the appropriate contraceptive measures. These risks will be discussed each time you begin a new course of Lenalidomide. 6/22/11 Second Primary Risks of Lenalidomide Sometimes a second primary cancer arises after patients have undergone cancer treatment, including treatment using chemotherapeutic drugs used to treat multiple myeloma. Recently, in clinical trials of patients with newly diagnosed multiple myeloma, 2/29/08 Page 12 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form a higher number of second cancers has also been reported in patients treated with high doses of chemotherapy (also called induction therapy) and/or stem cell transplant followed by prolonged (or maintenance) lenalidomide treatment compared to those who received induction therapy and/or transplant without maintenance lenalidomide. We do not know at this time whether prolonged lenalidomide treatment in this clinical setting actually increases the risk of second primary cancers. No increase in second primary cancers has been observed in patients receiving lenalidomide treatment who have relapsed multiple myeloma or other types of cancer. We will be carefully monitoring these events (or second primary cancers) in on-going studies of lenalidomide treatment and will inform you if there are any changes. We want you to be aware of this possibility and to continue to follow standard medical advice for prevention and early detection of other cancers during and after your treatment. 7/1/11 Risks Associated with Pregnancy Lenalidomide is related to thalidomide. Thalidomide is known to cause severe lifethreatening human birth defects. Findings from a monkey study indicate that lenalidomide caused birth defects in the babies of female monkeys who received the drug during pregnancy. If lenalidomide is taken during pregnancy, it may cause birth defects or death to any unborn baby. Women must not become pregnant while taking lenalidomide. You have been informed that the risk of birth defects is unknown. If you are female, you agree not to become pregnant while taking lenalidomide. When taking lenalidomide, the drug is present in semen of healthy men at very low levels for three days after stopping the drug. For patients who may not be able to get rid of the drug, such as people with kidney problems, lenalidomide may be present for more than three days. To be safe, all men should use condoms when engaging in sexual intercourse while taking lenalidomide, when temporarily stopping lenalidomide, and for 28 days after permanently stopping lenalidomide treatment if their partner is either pregnant or able to have children. Patients should not donate blood during study treatment or for 28 days following discontinuation of lenalidomide. You will be counseled at least every 28 days during lenalidomide treatment and again one last time when you stop taking lenalidomide about not sharing lenalidomide (or other study drugs), the potential risks of fetal exposure, abstaining from blood and other donations, the risk of changes in blood counts and blood clots, and you will be reminded not to break, chew or open lenalidomide capsules. You will be provided with the “Lenalidomide Information Sheet for Patients Enrolled in Clinical Research Studies” with each new supply of lenalidomide as a reminder of these safety issues. 2/29/08 Page 13 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Risks and side effects related to the prednisone include those which are: Likely: (Updated 9/25/09) An increase in the number of white blood cells Appetite loss or increased appetite and weight gain Stomach ulcer Skin wasting (thinning of the skin) Hair growth on the face Acne Facial redness Increased sweating Bruising Irregular or absent periods Insomnia (trouble falling asleep) Muscle weakness Elated moods Headache Swelling in arms and legs Fluid retention High blood pressure Increased levels of potassium Cataracts Elevated blood sugar Aggravation or cause of diabetes Changes in adrenal gland (organs that produce hormones) that lead to rounding of the face Brittleness of the bones resulting in back pain Lowering of immunity Muscle wasting Increased likelihood of infection Less Likely: Vomiting Nausea Rash Serious infections Protrusion of the eyeballs Increased pressure inside the eyes Seizures Psychosis Depression Dizziness 2/29/08 Page 14 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Risks and side effects related to Melphalan include the following: More Likely: Low white blood cells Low platelet count Hair Loss Inability to eat or drink due to mouth sores Less Likely: Inflammation of the skin Itching Nausea Vomiting Rare: 9/16/09 ● Inflammation of blood vessels that may result in kidney damage and rash Diarrhea Hypersensitivity (skin rash) Low red blood cells due to destruction by the immune system Lung scarring Lung inflammation Secondary tumors Important Information and Warnings for All Patients Taking Lenalidomide or Thalidomide Warning: Serious Human Birth Defects If Lenalidomide or Thalidomide IS taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Lenalidomide or 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 Lenalidomide or 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 Lenalidomide or 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 Lenalidomide or Thalidomide. 2/29/08 Page 15 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form INIT: 3. I understand that if I am able to become pregnant, I must use at least two methods of birth control; one highly effective method and an additional effective method of birth control (contraception): Examples of highly effective methods: IUD Additional Methods: Latex condom Hormonal (birth control pills, injections, or implants) Diaphragm Tubal ligation Cervical cap Partner’s vasectomy These birth control methods must be used for at least 4 weeks before starting Lenalidomide or Thalidomide therapy, during Lenalidomide or Thalidomide therapy, and for at least 4 weeks after completing Lenalidomide or Thalidomide therapy. I must use these methods even if I am infertile. I do not have to use them if I have had a hysterectomy or if I have been post-menopausal for at least 24 months (been through the changes of life) or 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: INIT: INIT: INIT: 2/29/08 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 Lenalidomide or Thalidomide therapy, and every week during the first 4 weeks of Lenalidomide or Thalidomide therapy. I will then have a pregnancy test every 4 weeks if I have regular menstrual cycles, or every 2 weeks if my cycles are irregular while I am taking Lenalidomide or Thalidomide. 5. I know that I must immediately stop taking Lenalidomide or Thalidomide and inform my doctor if I become pregnant while taking the drug, if I miss my menstrual period, 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 1-888-668-2528 for information on emergency contraception. 6. I am not now pregnant, nor will I try to become pregnant for at least 4 weeks after I have completely finished taking Lenalidomide or Thalidomide. 7. I understand that Lenalidomide or 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. Page 16 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form INIT: INIT: 8. I understand Lenalidomide or Thalidomide can cause side effects including nerve damage (numbness, tingling or pain in the hands or 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 l Lenalidomide or Thalidomide. 9. My doctor has answered any questions I have asked. CONSENT FOR MEN: INIT: 1. I understand that I must not take Lenalidomide or 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 Lenalidomide or Thalidomide during pregnancy. INIT: 3. My doctor has told me that I must NEVER have unprotected sex with a woman while taking Lenalidomide or Thalidomide because the drug is known to be 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 Lenalidomide or 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 1-888-6682528 for information on emergency contraception. INIT: 5. I understand that Lenalidomide or 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: 6. I understand Lenalidomide or 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 2/29/08 Page 17 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form INIT: 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 Lenalidomide or Thalidomide. 7. My doctor has answered any questions I have asked. Authorization: This information 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 Lenalidomide or Thalidomide. I now authorize my doctor to begin my treatment with Lenalidomide or Thalidomide. Participant Name (please print) Participant Signature Date (mo/day/yr) 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 Lenalidomide or 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. Physician Name (please print) Physician Signature Date (mo/day/yr) 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 Lenalidomide. You will be monitored for kidney problems before each pamidronate or zoledronic acid treatment you receive. Also the main risks of enteric coated aspirin are bleeding complications which can be serious or life-threatening. Are there benefits to taking part in the study? Taking part in this study may or may not make your health better. While doctors hope the therapies used on this study will be more useful against cancer compared to the usual treatment, there is no proof of this yet. We do know that the information from this study will help doctors learn more about the treatments for cancer and that this information could help future cancer patients. 2/29/08 Page 18 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form What other choices do I have if I do not take part in this study? Your other choices may include: Getting treatment or care for your cancer without being in a study Getting treatment or care for your cancer with other drugs which work in myeloma such as dexamethasone or bortezomib. Having a blood stem cell transplant Taking part in another study Getting no treatment Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible. Talk to your doctor about your choices before you decide if you will take part in this study. Will my medical information be kept private? The Eastern Cooperative Oncology Group (ECOG) is conducting this study. ECOG is a cancer research group that conducts studies for the National Cancer Institute. Your doctor is a member of ECOG or another group that is participating in this study. 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 proceeding. Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation purposes. You should know that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about you or your involvement in this research. 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 privacy. You should also understand that your doctor and ECOG may take steps, including reporting to authorities, to prevent you from seriously harming yourself or others. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. 2/29/08 Page 19 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form 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 Qualified representatives of Celgene Pharmaceutical Company Central laboratories, central banks and/or reviewers Possible other federal or state government agencies 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. What are the costs of taking part in this study? 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, x-rays, scans, chemotherapy treatments, radiation treatments, and any other tests. Please ask your doctor about any added costs or insurance problems. The study agents, Thalidomide and Lenalidomide will be provided free of charge while you are participating in this study. However, if you should need to take Thalidomide or Lenalidomide much longer than is usual, it is possible that the free supply of Thalidomide or Lenalidomide given to the NCI could run out. If this happens, your study doctor will discuss with you how to obtain additional drug from the manufacturer and you may be asked to pay for it. 2/29/08 Page 20 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form You will not be paid for taking part in this study. For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute’s Web site at http://cancer.gov/clinicaltrials/understanding/ insurancecoverage. You can print a copy of the “Clinical Trials and Insurance Coverage” information from this Web site. Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free copy. What happens if I am injured because I took part in this study? It is important that you tell your study doctor, _________________________ if you feel that you have been injured because of taking part in this study. You can tell the doctor in person or call him/her at #____________________________. You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment. Although no funds or monies have been set aside to compensate you in the event of injury or illness related to the study treatment or procedures, you do not waive any of your legal rights for compensation by signing this form. You or your insurance company will be charged for continuing medical care and/or hospitalization. What are my rights if I take part in this study? Taking part in this study is voluntary. You may choose to take part, not to take part, or may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care or result in any penalty or loss of benefits to which you are entitled. 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. We will tell you about new information that may affect your health, welfare or willingness to stay in this study. You may be asked to sign another consent form in response to new information. 2/29/08 Page 21 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form A Data Safety and Monitoring Committee (DSMC), an independent group of experts, will be reviewing the data from this research throughout the study. The DSMC is a committee assigned to a randomized clinical trial charged or obligated with the responsibility of monitoring performance of the trial, safety of the participants, and effectiveness of the treatments being tested. 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 ______________________). Please note: This section of the informed consent form is about additional research studies that are being done with people who are taking part in the main study. You may take part in these additional studies if you want to. You can still be a part of the main study even if you say ‘no’ to taking part in any of these additional studies. 9/16/09 You can say “yes” or “no” to each of the following studies. Please circle your choice for each study. Scientific Studies This study includes one or more laboratory tests that will analyze a small sample of blood and bone marrow. The samples will be collected from your blood stream through a needle stick into your vein or through your central venous catheter. During your routine bone marrow sampling, an additional sample (1 teaspoon) will be collected. The blood and marrow samples will be sent to a laboratory, where tests will be performed. Researchers will perform these tests in order to understand the biology of Multiple Myeloma. 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 they will not be used in planning your care. You or your insurance will not be charged 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 research studies. If you have any questions, please talk to your doctor or nurse, or call our research review board at phone # ________________________. 2/29/08 Page 22 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form I agree to participate in the scientific laboratory tests that are being done as part of this study. Yes No Will Any of the Samples (e.g., Tissue) Taken from Me Be Used for Other Research Studies? If you participate in the laboratory study associated with this protocol, you are going to have some bone marrow and blood collected, which will be sent to a central laboratory for analysis. We would like to keep some of the bone marrow and blood that may be left over for future research. If you agree, this bone marrow and blood will be kept and may be used in research to learn more about cancer and other diseases. This bone marrow and blood will be given only to researchers approved by the Eastern Cooperative Oncology Group (ECOG). Any research done on the bone marrow and/or blood must also be approved by the researcher’s Institutional Review Board. Your bone marrow and blood may be helpful for research. The research that may be done with your bone marrow and blood will probably not help you. It might help people who have cancer and other diseases in the future. Reports about the research done with your bone marrow and blood will not be given to you or to your doctor. These reports will not be put into your health record. The research will not have an effect on your care. Things to Think About The choice to let us keep the leftover bone marrow and blood 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 the Eastern Cooperative Oncology Group study. If you decide now that your bone marrow and blood 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 bone marrow and blood. If your blood or bone marrow were already sent to a researcher to be used for a project when you withdraw consent, your specimens and accompanying data will still be used for that approved project. Once you choose to end your participation, no further specimens or related information will be sent to researchers for any new research projects. 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. 2/29/08 Page 23 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form Sometimes bone marrow and blood used for genetic research (about disease that are passed on in families). Even if your bone marrow and blood are used for this kind of research, the results will not be put into your health records. Your bone marrow and blood will be used only for research, and it will not be sold. You will not be paid for allowing your leftover bone marrow and blood to be used in research, even though the research done with your bone marrow and blood may help to develop new products in the future. Similarly, there will be no cost to you for any bone marrow and blood collected and stored by the Eastern Cooperative Oncology Group. It is possible that, at some time in the future, as part of deciding on which therapy to give you, a new test might become available that could be done on some of the bone marrow and blood that is now thought of as “leftover.” This situation is unusual, but it could happen. In order to see that not all of this leftover bone marrow and blood is used up, the Eastern Cooperative Oncology Group will take care to see that some of your cancer bone marrow and blood is stored for 10 years so it is available if you or your doctors should need it. This will depend upon the amount of leftover bone marrow and blood that is submitted for this study. However, there may not be any leftover bone marrow and blood to store. Benefits The benefits of research using bone marrow and blood 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. 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 bone marrow and blood research studies. If you have any questions, please talk to your doctor or nurse or call our Institutional Review Board at phone # _________. My bone marrow and blood may be kept for use in research to learn about, prevent, treat, or cure cancer. Yes No 2/29/08 Page 24 of 25 Participant Initials _____ IRB Approval _______________ Version: 10/4/11; Addendum #11 Broadcast: 10/5/11 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Consent Form My bone marrow and blood may be kept for use in research about other health problems (for example, causes of diabetes, Alzheimer’s disease, and heart disease). Yes No 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 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 Participant Agreement 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 25 pages of this consent. I have read it or it has been read to me. I may also request a copy of the study (complete study plan). ______________ (Date) _________________________________ (Participant Signature) I certify that I have explained to the above individual the nature and purpose, the potential benefits, and possible risks associated with participation in the research study and have answered any questions that have been raised. ______________ (Date) 2/29/08 _________________________________ (Signature of Person Obtaining Consent) Page 25 of 25 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Withdrawal of Consent 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 ___________ 2/29/08 CTSU/ECOG E1A06 Southeast Cancer Control Consortium Withdrawal of Treatment Consent 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 __________ 2/29/08
