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blood and bone marrow samples

Throughout the study, we will collect blood and marrow samples to check if the treatments are working. These samples are being done as a part of the standard of care disease assessment. In addition, blood and marrow samples are also collected as part of this research study to check your immune response to the vaccine and are not part of your standard of care. The maximum amount of blood we will collect for this study in one day is 70mL (approximately 4.5 tablespoons). If more blood is required at a particular time, we will collect blood on 2 or more days spread out over 1-2 weeks. The maximum amount of bone marrow sample we will collect is 37mL (approximately 2.5 tablespoons). **Table 5** shows the timeline and amount of samples we may collect from you during the study.  
Table 5: Timeline and Sample Amount Collected during Study (in approximate tablespoons (Tbsp) or teaspoons (tsp))  
| When  you join  the  study                          | Maintenance Cycles   |         |         |      |      |      |        |     |
|-----------------------------------------------------|----------------------|---------|---------|------|------|------|--------|-----|
| Before  you're                                      |                      |         |         |      |      |      |        |     |
| randomized                                          |                      |         |         |      |      |      |        |     |
| Sample                                              | 1                    | 2       | 2       | 3    | 4    | 4    | 9      |     |
| (day 7)                                             | (day 7)              |         |         |      |      |      |        |     |
| Bone marrow                                         | 2.5 Tbsp             | 1 tsp   | 2 tsp   |      |      |      |        |     |
| Optional bone  marrow  samples for  future research | <1 tsp               | <1 tsp  | <1 tsp  |      |      |      |        |     |
| 6.5 Tbsp                                            |                      |         |         |      |      |      |        |     |
| Blood-forming  cells                                | 2 Tbsp               | 4.5     | 4.5     | 4    | 4.5  | Tbsp | 4 Tbsp | 4.5 |
| 4.5                                                 |                      |         |         |      |      |      |        |     |
| *over 10                                            | Tbsp                 | Tbsp    | Tbsp    | Tbsp | Tbsp |      |        |     |
| days                                                |                      |         |         |      |      |      |        |     |
| Optional blood  samples for                         | 1.5 tsp              | 1.5 tsp | 1.5 tsp |      |      |      |        |     |
| future research                                     |                      |         |         |      |      |      |        |     |
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6. risks and discomforts

You may have side effects while on the study. Side effects can range from mild to serious. The risks and discomforts of autologous transplant are the same if you join this study, or if you don't join this study. You might do better or worse than you would with a standard transplant. Your healthcare team may give you medicines to help with side effects like nausea (feeling sick to your stomach). In some cases, side effects can last a long time or may never go away.
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risks of making the vaccine

We will collect bone marrow samples on all patients. We will take the bone marrow samples from your hip bone with a large needle. This is called a bone marrow aspirate. After, you may feel pain and bleed at the site where the needle went in your hip. A small number of patients will have pain that runs down their legs, pain that lasts more than a few days, and/or get an infection. If you are assigned to Treatment Group A, we will collect blood and bone marrow samples to make the vaccine (see Table 5. **Timeline and Sample Amount Collected during Study**). We will also collect extra samples of blood through a catheter in your neck or chest (leukaphereis). The risks of leukapheresis include:
- Bleeding
- Punctured lung (hole in lung)  
- Infection
- Low blood cell counts.
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risks of medications

The risks of the chemotherapy and maintenance drugs you will get as part of the treatment are listed below.  
| Likely                                     | Less Likely                                                             | Rare, but Serious                         |                                             |    |                    |
|--------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------|----|--------------------|
| (May happen in more than  20% of patients) | (May happen in less than 20% of  patients)                              | (May happen in less than 2% of  patients) |                                             |    |                    |
| -                                          | Loss of appetite                                                        | -                                         | Changes in heart beat                       | -  | Allergic reaction  |
| -                                          | Constipation                                                            | -                                         | Lung infection                              |    |                    |
| -                                          | Dizzy                                                                   |                                           |                                             |    |                    |
| -                                          | Diarrhea                                                                | -                                         | Scarring of lung tissue                     |    |                    |
| -                                          | Feeling faint                                                           |                                           |                                             |    |                    |
| -                                          | Nausea (feeling sick  to your stomach)                                  | -                                         | Seizure                                     |    |                    |
| -                                          | Shortness of breath                                                     | -                                         | Vasculitis (inflammation of  blood vessels) |    |                    |
| -                                          | Vomiting (throwing  up)                                                 | -                                         | Hepatitis (swelling of the  liver)          | -  | Low blood pressure |
| -                                          | Temporary hair loss                                                     | -                                         | Sweating too much                           |    |                    |
| -                                          | Kidney failure                                                          |                                           |                                             |    |                    |
| -                                          | Sensitive skin                                                          | -                                         | Sterility (unable to have  children)        |    |                    |
| -                                          | Weight loss                                                             |                                           |                                             |    |                    |
| -                                          | Infection                                                               |                                           |                                             |    |                    |
| -                                          | Low number of white  blood cells                                        | -                                         | Liver damage                                |    |                    |
| -                                          | Feeling weak                                                            | -                                         | Heart stops beating                         |    |                    |
|                                           | Low number of  platelets in the blood  with increased risk of  bleeding | -                                         | New cancer of bone marrow  cells            |    |                    |
| -                                          | Anemia (low number  of red blood cells)                                 |                                           |                                             |    |                    |
| -                                          | Mouth sores                                                             |                                           |                                             |    |                    |
| -                                          | Sore throat (red with  swelling)                                        |                                           |                                             |    |                    |
| -                                          | Skin breakdown (if  drug leaks from vein)                               |                                           |                                             |    |                    |
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melphalan - conditioning regimen drug

| Likely                                     | Less Likely                                                 | Rare, but Serious                        |                                                                                                          |    |                                            |
|--------------------------------------------|-------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------|----|--------------------------------------------|
| (May happen in more than  20% of patients) | (May happen in less  than 20% of patients)                  | (May happen in less than 2% of patients) |                                                                                                          |    |                                            |
| -                                          | Twitching (at  injection site)                              | -                                        | Fluid retention  (too much water  in your body)                                                          |    |                                            |
| -                                          | Itching (general or  at injection site)                     | -                                        | Fatigue                                                                                                  |    |                                            |
| -                                          | Discomfort (at  injection site)                             | -                                        | Muscle aches                                                                                             |    |                                            |
| -                                          | Itching                                                     |                                          |                                                                                                          |    |                                            |
| -                                          | Swelling (at  injection site)                               | -                                        | Allergic reaction leading to rashes,  joint pain, kidney, heart or lung  damage, drop in blood counts    |    |                                            |
| -                                          | Fever                                                       |                                          |                                                                                                          |    |                                            |
| -                                          | Bruising at the  injection site                             | -                                        | Abnormal  Antinuclear  Antibody (ANA)  blood test                                                        | -  | Tumor growth or the spread of your  cancer |
| -                                          | Infection at the vaccine site                               |                                          |                                                                                                          |    |                                            |
| -                                          | Decreased white  blood cell count  (including  neutrophils) | -                                        | Change in thyroid function (fatigue,  weight gain, sensitivity to cold and  lack of interest or emotion) |    |                                            |
| -                                          | Headache                                                    | -                                        | Pulmonary embolus (blood clot in  the lungs)                                                             |    |                                            |
| -                                          | Diarrhea                                                    |                                          |                                                                                                          |    |                                            |
| -                                          | Feeling light  headed                                       |                                          |                                                                                                          |    |                                            |
| -                                          | Flu-like  symptoms                                          |                                          |                                                                                                          |    |                                            |
| -                                          | Night sweats                                                |                                          |                                                                                                          |    |                                            |  
| Likely                                     | Less Likely                                | Rare, but Serious                        |
|--------------------------------------------|--------------------------------------------|------------------------------------------|
| (May happen in more than  20% of patients) | (May happen in less  than 20% of patients) | (May happen in less than 2% of patients) |
| -                                          | Elevated TSH (TSH is a thyroid  hormone)   |                                          |
| -                                          | Candida  infection                         |                                          |  
| GM-CSF (Leukine) Likely                    | Less Likely                                             | Rare, but Serious                         |                                      |    |             |
|--------------------------------------------|---------------------------------------------------------|-------------------------------------------|--------------------------------------|----|-------------|
| (May happen in more than  20% of patients) | (May happen in less than 20%  of patients)              | (May happen in less than  2% of patients) |                                      |    |             |
| -                                          | Fever                                                   | -                                         | Rapid, irregular heartbeats          | -  | Blood clots |
| -                                          | Chills                                                  | -                                         | Feeling lightheaded or  dizzy        |    |             |
| -                                          | Nausea                                                  | -                                         | Allergic reaction                    |    |             |
| -                                          | Vomiting                                                | -                                         | Fluid in lungs or around  your heart |    |             |
| -                                          | Diarrhea                                                |                                           |                                      |    |             |
| -                                          | Fatigue                                                 | -                                         | Changes in vision                    |    |             |
| -                                          | Feeling weak                                            | -                                         | Low blood cell counts                |    |             |
| -                                          | Headache                                                | -                                         | Infection at needle  injection site  |    |             |
| -                                          | Loss of appetite                                        |                                           |                                      |    |             |
| -                                          | Flushed face (red or pink  cheeks)                      |                                           |                                      |    |             |
| -                                          | Bone and muscle pain in  arms, legs and feet            |                                           |                                      |    |             |
| -                                          | Red skin, swelling, or itching at needle injection site |                                           |                                      |    |             |
| -                                          | Low blood pressure                                      |                                           |                                      |    |             |
| -                                          | Shortness of Breath                                     |                                           |                                      |    |             |
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lenalidomide- maintenance treatment drug

| Likely                                     | Less Likely                                                | Rare, but Serious                         |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
|--------------------------------------------|------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (May happen in more  than 10% of patients) | (May happen in less than 10% of  patients)                 | (May happen in less than 2% of  patients) |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Low number of  white blood cells  (with or without  fever) | -                                         | Abnormally low number of  blood cells                                                                                                                                                                          | -  | Swelling of lungs                                                                                                                                                                                                                                                                                                                                                    |
| -                                          | Over and underactive thyroid                               |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Destruction of red blood cells                             | -                                         | Severe allergic conditions  including: Swelling under  skin; Severe skin reactions  involving lining of the nose,  mouth, stomach and intestines  or rash leading to the  separation of the top layer of  skin |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Heart attack                                               |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Anemia; Decrease  in cells that help  your blood clot      | -                                         | Abnormal heart beats                                                                                                                                                                                           |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Heart stops working                                        |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Vision Blurred                                             | -                                         | Low oxygen to heart tissue                                                                                                                                                                                     |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Diarrhea                                                   | -                                         | Dry mouth                                                                                                                                                                                                      |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Pain, Constipation                                         | -                                         | Decreased action of intestine                                                                                                                                                                                  | -  | Tumor Lysis Syndrome  (TLS) is caused by the  sudden, rapid death of cancer  cells in response to treatment.  When cancer cells die they  may spill their inner  (intracellular) contents, which  accumulate faster than they  can be eliminated. This debris  from the cancer cells can  change the balance of the  chemistry of the body, which  can be dangerous. |
| -                                          | Indigestion                                                | -                                         | Bile flow from liver slowed  or blocked                                                                                                                                                                        |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Nausea                                                     |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Vomiting                                                   | -                                         | Gout                                                                                                                                                                                                           |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Feeling weak and  unwell                                   | -                                         | Fall                                                                                                                                                                                                           |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Bruise                                                     |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Tired                                                      | -                                         | Lowered level of  consciousness with  drowsiness, listlessness, and  apathy                                                                                                                                    |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Swelling                                                   |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Fever                                                      |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Chills                                                     | -                                         | Abnormal liver lab tests                                                                                                                                                                                       |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Pneumonia or  other infections                             | -                                         | Increase in liver protein that  indicates inflammation in  body                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Sore throat                                                |                                           |                                                                                                                                                                                                                |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Stuffy nose                                                | -                                         | Loss of fluid                                                                                                                                                                                                  |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Weight loss                                                | -                                         | Diabetes                                                                                                                                                                                                       |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | Decreased appetite                                         | -                                         | High uric acid in blood                                                                                                                                                                                        |    |                                                                                                                                                                                                                                                                                                                                                                      |
| -                                          | High blood sugar                                           | -                                         | Iron build up in body                                                                                                                                                                                          |    |                                                                                                                                                                                                                                                                                                                                                                      |  
Version 4.0 dated *July 24, 2018*  
| Version 4.0 dated July 24, 2018                                                                           |                                                                                                                                                                        |    |                                                                                                                                          |
|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|------------------------------------------------------------------------------------------------------------------------------------------|
| -                                                                                                         | Chemical  imbalance in blood                                                                                                                                           | -  | Muscle weakness                                                                                                                          |
| -                                                                                                         | Cancer                                                                                                                                                                 |    |                                                                                                                                          |
| -                                                                                                         | Pain including  muscles, joints,  and non-cardiac  chest pain                                                                                                          | -  | Stroke                                                                                                                                   |
| -                                                                                                         | Tingling of skin                                                                                                                                                       |    |                                                                                                                                          |
| -                                                                                                         | Fainting                                                                                                                                                               |    |                                                                                                                                          |
| -                                                                                                         | Dizziness                                                                                                                                                              | -  | Moody                                                                                                                                    |
| -                                                                                                         | Altered sense of  taste                                                                                                                                                | -  | Kidney failure                                                                                                                           |
| -                                                                                                         | Headache                                                                                                                                                               | -  | Breathing disorder                                                                                                                       |
| -                                                                                                         | Excessive sweating                                                                                                                                                     |    |                                                                                                                                          |
| -                                                                                                         | Eye lens cloudy                                                                                                                                                        |    |                                                                                                                                          |
| -                                                                                                         | Abnormal sense of  touch                                                                                                                                               | -  | Night sweats                                                                                                                             |
| -                                                                                                         | Skin redness                                                                                                                                                           |    |                                                                                                                                          |
| -                                                                                                         | Pain and decreased  sensation in nerves                                                                                                                                | -  | Swelling of skin filled with  blood                                                                                                      |
| -                                                                                                         | Shaking                                                                                                                                                                | -  | Swelling of blood vessels                                                                                                                |
| -                                                                                                         | Cough                                                                                                                                                                  | -  | High or low blood pressure                                                                                                               |
| -                                                                                                         | Shortness of  breath                                                                                                                                                   | -  | Blood not getting to  extremities                                                                                                        |
| -                                                                                                         | Nosebleed                                                                                                                                                              | -  | Clot in vein                                                                                                                             |
| -                                                                                                         | Blood clot in  lower extremities,  lungs, heart, brain,  and other organs                                                                                              | -  | Sudden increase in tumor size                                                                                                            |
| -                                                                                                         | Rapid death of cancer cells  where the accumulating  contents of dying cancer cells  cause an imbalance in the  chemistry of the body which  can lead to kidney damage |    |                                                                                                                                          |
| -                                                                                                         | Dry skin                                                                                                                                                               |    |                                                                                                                                          |
| -                                                                                                         | Itching                                                                                                                                                                |    |                                                                                                                                          |
| -                                                                                                         | Allergic reaction                                                                                                                                                      | -  | Blood cancer that causes  decreased number of red  blood cells, white blood cells,  and platelets because they do  not develop normally. |
| -                                                                                                         | Feeling sad                                                                                                                                                            |    |                                                                                                                                          |
| -                                                                                                         | Not sleeping well                                                                                                                                                      |    |                                                                                                                                          |
| You shouldn't donate blood while you're in the study and for 28 days after you stop taking  lenalidomide. |                                                                                                                                                                        |    |                                                                                                                                          |
table 2 treatment group a
risk to the unborn

Lenalidomide can cause severe birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Because of this, it is extremely important that you don't get pregnant while you're taking lenalidomide. If you're pregnant or nursing, you're not eligible to take part in this study. Women who can become pregnant must use **at least 2 forms of effective birth control** while in the study or abstain from all reproductive sexual intercourse. Effective birth control is defined as the following:
1. Refraining from all acts of vaginal sex (abstinence)  
2. Consistent use of birth control pills
3. Injectable birth control methods (Depo-Provera, Norplant) 4. Tubal sterilization or male partner who has undergone a vasectomy  
5. Placement of an IUD (intrauterine device) 6. Use of a cervical cap or a diaphragm with contraceptive jelly and/or condoms with contraceptive foam every time you have sex.
Females taking lenalidomide have blood clots more often. Because of this, you should talk to your doctor about birth control pills and hormone replacement therapy, and the risks and benefits. You do not need to use effective birth control only if you are a woman and cannot have children because you:
Had a hysterectomy (your ovaries and uterus were removed), OR Had a bilateral oophorectomy (your ovaries were removed), OR
Went through menopause (post-menopausal).
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reproductive risks

The drugs used in this research study may damage your reproductive organs, affect your ability to have children, or cause birth defects if you take them while you are pregnant or nursing. Both women who can become pregnant and their male partners should use birth control while on this study and for 28 days after maintenance treatment is stopped. **If you or your partner** becomes pregnant during this study, you must tell the study doctor immediately. Your doctor will discuss the risks to your unborn child and options with you. It is important that females who aren't pregnant or nursing don't become pregnant while part of the study. If you are a woman and become pregnant while on this study, we will stop the maintenance treatment drug right away. Your study doctor will watch your health closely while you are pregnant and for 30 days after the pregnancy ends.
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females who join the study

If you are female and can become pregnant, you will need to take a pregnancy test before you start the study. You should discuss ways to prevent pregnancy while you're in the study. Women who have gone through puberty might experience irregular menstrual cycles or their cycle might stop forever. This doesn't mean that you can't become pregnant. You must still use 2 effective forms of birth control during the study and continue with it for 28 days after you finish maintenance treatment. Be sure to talk with your doctor about options for fertility planning, like storing your eggs, before starting chemotherapy treatment.
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males who join the study

If you are male, your body may not be able to produce sperm (become sterile). Be sure to talk with your doctor about options for fertility planning, like banking your sperm, before starting chemotherapy treatment.
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damage to the vital organs

Your vital organs include your heart, lungs, liver, intestines, kidneys, bladder and brain. The chemotherapy drugs may hurt these organs. You may develop lung problems from chemotherapy or an infection. Some patients can have veno-occlusive disease (VOD) of the liver. Patients with VOD become jaundiced (yellow skin), have problems with their liver, retain too much water (feel swollen and uncomfortable), and have stomach swelling and pain. If there is serious damage to your vital organs, you may have to stay in the hospital longer or return to the hospital after your transplant. Many patients get better, but these complications can cause permanent damage to your organs or death.
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relapse (return) of disease or

Your disease may come back even if the transplant was successful at first. We don't know if new blood cancers are caused by lenalidomide or other drugs. Other research looked at the number of patients who got new blood cancers after taking lenalidomide for:
Diseases other than multiple myeloma, AND  
Relapsed multiple myeloma.
In these studies, no difference was shown in the number of patients who got new blood cancers. Researchers for other studies of lenalidomide are still watching patients to see if they get new blood cancers. We will give you any new information that we learn about new blood cancers.
table 2 treatment group a
all patients taking lenalidomide

In order to participate in this study you must register into and follow the requirements of the REVLIMID REMS™ program of Celgene Corporation. This program provides education and counseling on the risks of fetal exposure, blood clots and reduced blood counts. You will be required to receive counseling every 28 days during treatment with lenalidomide, follow the pregnancy testing and birth control requirements of the program that are appropriate for you and take telephone surveys regarding your compliance with the program. You have been informed of the risk of birth defects. If you are female, you agree not to become pregnant while taking lenalidomide. For this reason, lenalidomide is provided to patients under a special distribution program called REVLIMID REMS TM.
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. other information

There may be some unknown or unanticipated discomforts or risks associated with this treatment in addition to those specified above, but every precaution will be taken to assure your personal safety and to minimize discomforts. Throughout the study, the researchers will tell you of new information that might affect your decision to remain in the study. If you wish to discuss the information above or any other discomforts you may experience, you may ask questions now or call your doctor _______________________, the Principal Investigator or contact person listed on the front page of this form.
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other risks serious infections

It may take many months for your immune system to recover from the chemotherapy and maintenance therapy drugs. There is an increased risk of infection during this time when your body is healing. We will give you drugs to reduce the chance of infection, but they may not work. If you have an infection, you may have to stay in the hospital longer or return to the hospital after transplant. Many patients get better, but some infections can cause death.
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unforeseen risks

Chemo drugs can damage your blood cells, which may cause a new blood cancer to grow. We know from other MM research studies, that more patients had a second cancer after chemo and/or autologous transplant with maintenance lenalidomide than those who didn't get lenalidomide. We don't know if taking lenalidomide for a long time raises the risk of having a second cancer. Other new risks might appear at any time during the study. These risks might be different from what is listed in this Consent Form. There may be some unknown or unanticipated discomforts or risks associated with this treatment in addition to those specified above, but every precaution will be taken to assure your personal safety and to minimize discomforts.
table 2 treatment group a
other treatments or medicines

Some medicines react with each other, and it is important that you tell the study doctor or staff about any other drugs, treatments, or medicines you are taking. This includes non-prescription or over-the-counter medicines, vitamins, and herbal treatments. It is also important that you tell the study staff about any changes to your medicines while you're in the study. For more information about risks and side effects, ask your study doctor.
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7. other treatments

Participation in this study is optional. If you choose not to take part, you may still receive nontransplant treatments or an autologous or an allogeneic transplant to treat your disease. The treatment and evaluations you would receive could be very similar to what would receive if you join this study. Your study doctor will talk with you about your options. If you decide not to participate in this study, your medical care will not be affected in any way. Your other options may include:  
- Treatment with other drugs, radiation, or a combination of drugs and radiation without a transplant.  
- An allogeneic (donor) blood or marrow transplant that is not part of the study, or another type of transplant
- Participation in another clinical trial, if available (check with your doctor)
- No treatment for your blood cancer at this time
- Comfort care
Every treatment option has benefits and risks. Talk with your doctor about your treatment choices before you decide if you will take part in this study.
table 2 treatment group a
8. possible benefits

Taking part in this study may or may not make your health better. The information from this study will help doctors learn more about drugs used to treat MM. This information could help people with multiple myeloma who may need a transplant in the future.
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9. new information available during

During this research study, the study doctors may learn about new information about the study drugs or the risks and benefits of the study. If this happens, they will tell you about the new information. The new information may mean that you can no longer participate in the study, or that you may not want to continue in the study. If this happens, the study doctor will stop your participation in the study and will offer you all available care to suit your needs and medical conditions.
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10. privacy confidentiality and use

Your privacy is very important to us. The study doctors will make every effort to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not identify who you are. Data regarding your clinical situation, including follow-up after 2 years, may be obtained from the CIBMTR, which captures information on all US transplants. All your medical and demographic information (such as race and ethnicity, gender and household income) will be kept private and confidential. *(Name of Transplant Center)* and the organizations listed below will not disclose your participation by any means of communication to any person or organization, except by your written request, or permission, or unless required by federal, state or local laws, or regulatory agencies. The individuals below will have access to your research and medical information. They may use this information for inspections or audits to study the outcomes of your treatment. By agreeing to participate, you consent to such inspections and to the copying of parts of your records, if required by these organizations. We may give out your personal information 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. Information about your transplant from your original medical records may be seen or sent to national and international transplant registries, including:
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1. /institution/

2. The Center for International Blood and Marrow Transplant Research (CIBMTR)  
3. The National Marrow Donor Program (NMDP) 4. The Food and Drug Administration (FDA) 5. The National Institutes of Health (NIH), which include the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI)
6. Data and Coordinating Center of the Blood and Marrow Transplant Clinical Trials Network
(BMT CTN)
7. Data and Safety Monitoring Board (DSMB), not part of /Institution/
table 2 treatment group a
8. study investigators.

9. Celgene, the manufacturer of lenalidomide
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. For questions about access to your medical records, please contact /name/ at /number.
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11. ending your participation

The study doctor or the study sponsor may stop the study at any time, and we may ask you to leave the study. We may ask you to leave the study if you do not follow directions or if you suffer from side effects of the treatment. If we ask you to leave the study, the reasons will be discussed with you. Possible reasons to end your participation in this study include:  
1. You do not meet the study requirements. 2. You need a medical treatment not allowed in this study. 3. The study doctor decides that it would be harmful to you to stay in the study. 4. You are having serious side effects. 5. You become pregnant. 6. You cannot keep appointments or take study drugs as directed. 7. The study is stopped for any reason.
You could have serious health risks if you stop treatment during the conditioning process before you receive your transplant. If you stop taking the immune suppressing drugs (see Section 6:
Risks and Discomforts) too soon after transplant, your body could reject the stem cells or you could develop serious complications and possibly die. We ask that you talk with the research doctor and your regular doctor before you leave the study. Your doctors will tell you how to stop safely and talk with you about other treatment choices. If you decide to leave this study after getting the study treatment, or are asked to leave by your doctor for medical reasons, you will need to come back to the doctor's office for tests for your safety. Even if you leave the study, the information collected from your participation will be included in the study evaluation, unless you specifically ask that it not be included.
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12. physical injury as a

It is important that you tell your doctor, __________________ *[investigator's name(s)]* or study staff 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 __________________ *[telephone number]*. You will get all available medical treatment if you are injured from taking part in this study. You and/or your health plan will be charged for this treatment. There is no provision for free medical care or monetary compensation from the study sponsor, The National Institutes of Health or the study contributor, Celgene Corporation. In case you are injured in this study, you do not lose any of your legal rights to ask for or receive payment by signing this form.
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13. compensation or payment

You will not be paid for your participation in this research study. You will not get compensation or reimbursement for any extra expenses (travel, meals, etc.) you may have through your participation on this trial. Taking part in this study might help researchers make products to sell. Celgene or others may profit from these products. You will not have any rights to the patents or discoveries that could happen from this research, and you will not receive any payments from it.
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14. costs and reimbursements

Most of the visits for this research study are standard medical care for your autologous transplant and will be billed to your insurance company. You and/or your health plan/insurance company will need to pay for some or all of the costs of standard treatment in this study. You or your insurance will not be charged for blood and marrow samples for research on this study. You will not pay for any extra tests that are being done for the study. Lenalidomide will be provided to you for free for two years. After that your doctor will discuss what treatment is best for you.  
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 if they will pay. For questions about your costs, financial responsibilities, and/or medical insurance coverage for your transplant and this study, please contact /Center/ Financial Counselor at /Number/. 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/insurance-coverage. 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.
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15. for more information

If you need more information about this study, or if you have problems while taking part in this study, you can contact the study doctor or his/her staff. They can be reached at the telephone numbers listed here:
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[insert name and contact details]

If you wish to speak to someone not directly involved in the study, or if you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact:
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[insert appropriate contact details]

The ethical aspects of this study have been reviewed and approved by [name of IRB].
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17. blood and bone marrow

This section of the informed consent form is about future research studies that will use blood and bone marrow samples from people who are taking part in the main study. You may choose to give samples for these future research studies if you want to. You can still be a part of the main study even if you say 'no' to give samples for future research studies. Researchers are trying to learn more about how the human body processes the drugs used for transplant and how the body recovers after transplant. This research is meant to gain knowledge that may help people in the future and make transplants even more successful.  
If you agree to provide blood and bone marrow samples, here is what will happen:  
- We will collect 3 extra blood samples at the same time you have routine blood tests done
(Table 3):
o Around the time of your enrollment o About 2 months after your transplant o Before the start of your 9th cycle of maintenance therapy
- The amount of blood collected from you is about 1 teaspoon (6 ml) each time.  
- We will collect 3 bone marrow samples at the same time you have routine bone biopsies done. The amount of tissue collected from you is about a half of a teaspoon (3 mL) each time. We will collect samples at 3 different dates in the study (see **Table 3**):
o Around the time of your enrollment o About 2 months after your transplant o Before the start of your 9th cycle of maintenance therapy.  
- The blood and bone marrow samples will be sent to the BMT CTN Repository for processing and storage. A repository is a place that protects, stores and sends out samples for approved research studies. All research samples will be given a bar code that cannot be linked to you by future researchers testing your samples.  
- Materials stored in the Repository will be used mainly by clinicians and researchers in the BMT CTN network. In the future, the unused research samples and clinical data will be made available outside of this network.
- Researchers can apply to study the materials stored in the Repository. The BMT CTN
Steering Committee and/or the BMT CTN Executive Committee must approve each request before they will share samples or information with researchers. This is to make sure that the investigators requesting the samples are qualified, and that the research is of high quality.  
- DNA from your stored blood samples might be used in genome-wide association (GWA)
studies for a future project either done or supported by the National Institutes of Health (NIH). Genome-wide association studies are a way for scientists to find genes that have a role in human disease or treatment. Each study can look at hundreds of thousands of genetic changes at the same time. If your coded samples are used in such a study, the researcher is required to add your test results and sample information into a shared, public research database. This public database is called the NIH Genotype and Phenotype Database and it is managed by the National Center for Biotechnology Information (NCBI). The NCBI will never have any information that would identify you, or link you to your information or research samples.  
Some general things you should know about letting us store your blood samples for research are: 1. We will only store samples from people who give us permission.  
2. Research is meant to gain knowledge that my help people in the future. You will not get any direct benefit from taking part. Additionally, you or your doctor will not be given results and they will not be added to your medical record.  
3. A possible risk is the loss of confidentiality about your medical information. We will use safety measures with both your samples and clinical information to make sure that your personal information will be kept private. The chance that this information will be given to someone else is extremely small.  
4. Your blood will be used only for research and will not be sold. The research done with your blood may help to develop new products in the future. You will not get paid for any samples or for any products that may be developed from current or future research.
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you can change your mind

We ask that you contact [*Principal Investigator]* in writing and let him/her know you do not want us to use your research samples or health information for research. His/her mailing address is on the first page of this form. However, samples and information that have already been shared with other researchers cannot be taken back or destroyed.
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making your choice

Please read each sentence below and think about your choice. After reading each sentence, please indicate your choice below. If you have any questions, please talk to your doctor or nurse, or call our research review board at _[*contact information].*
No matter what you decide to do, it will not affect your care.
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statement of consent for research

The purpose of storing blood and tissue samples, the procedures involved, and the risks and benefits have been explained to me. I have asked all the questions I have at this time and I have been told whom to contact if I have more questions. I have been told that I will be given a signed copy of this consent form to keep. I understand that I do not have to allow the use of my blood and tissue for research. If I decide to not let you store research samples now or in the future, it will not affect my medical care in any way. I voluntarily agree that my blood, tissue, and information can be stored indefinitely by the BMT
CTN and/or NHLBI Repositories for research to learn about, prevent, or treat health problems. I
also understand that my DNA and health information may or may not be used in genome-wide association studies.
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blood

I agree to allow my blood samples to be stored for research.  
I do not agree to allow my blood samples to be stored for research.
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bone marrow

I agree to allow my bone marrow samples to be stored for research.  
I do not agree to allow my bone marrow samples to be stored for research.
Signature Date Health Insurance Portability and Accountability Act 1 (HIPAA12) Authorization to use and disclose individual health information for research purpose
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- purpose

As a research participant, I authorize the Principal Investigators and the researcher's staff to use and disclose my individual health information for the purpose of conducting the research study:
Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions
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- individual health information to

My individual health information that may be used or disclosed to do this research includes:  
1. Demographic information (for example, date of birth, sex, weight). 2. Medical history (for example, diagnosis, complications with prior treatment). 3. Findings from physical exams. 4. Laboratory test results obtained at the time of work up and after transplant (for example, blood tests, biopsy results).  
- **Parties Who May Disclose My Individual Health Information**:
The researcher and the researcher's staff may collect my individual health information from:
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[list hospitals clinics or providers

The individual health information disclosed by parties listed in item c and information disclosed by me during the course of the research may be received and used by the following parties:
1. Dr. David Avigan, Co-Principal Investigator  
2. Dr. Nina Shah, Co-Principal Investigator 3. Dr. David Chung, Co-Principal Investigator 4. Celgene, its collaborators or designees 5. National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute
(NCI), both of the National Institutes of Health (NIH),
6. Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Data and Coordinating Center 7. U.S. government agencies that are responsible for overseeing research such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP)
8. U.S. government agencies that are responsible for overseeing public health concerns such as the Centers for Disease Control (CDC) and federal, state and local health departments.  
- **Right to Refuse to Sign this Authorization**:
I do not have to sign this Authorization. If I decide not to sign the Authorization, I will not be allowed to participate in this study or receive any treatment related to research that is provided through the study. My decision not to sign this authorization will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.
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- right to revoke

I can change my mind and withdraw this authorization at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw this authorization, the researcher may only use and disclose the protected health information already collected for this research study. No further health information about me will be collected by or disclosed to the researcher for this study.
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- potential for re-disclosure

My individual health information disclosed under this authorization may be subject to redisclosure outside the research study and no longer protected.  
Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures.
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- genetic information nondiscrimination act

A new federal law (2009), called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information. Health insurance companies and group health plans may not request your genetic information that we get from this research. This means that they must not use your genetic information when making decisions regarding insurability. Be aware that this new federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or longterm care insurance.  
- This authorization does not have an expiration date.  
TITLE: Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions PROTOCOL NUMBER: BMT CTN \#1401 PRINCIPAL INVESTIGATOR:
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fax

I have read and understood this Consent Form. The nature and purpose of the research study has been explained to me.  
- I have had the chance to ask questions, and understand the answers I have been given. I
understand that I may ask questions at any time during the study.  
- I freely agree to be a participant in the study.  
- I understand that I may not directly benefit from taking part in the study.  
- I understand that, while information gained during the study may be published, I will not be identified and my personal results will stay confidential.  
- I have had the chance to discuss my participation in this research study with a family member or friend.  
- I understand that I can leave this study at any time, and doing so will not affect my current care or prevent me from receiving future treatment.  
- I understand that I will be given a copy of this signed consent form.  
Participant Name Date Signature Date I certify that I have provided a verbal explanation of the details of the research study, including the procedures and risks. I believe the participant has understood the information provided.  
Name of Counseling Physician Date  
Signature of Counseling Physician Date  
APPENDIX B-2 INFORMED CONSENT DOCUMENTS FOR BMT CTN 1401 **OPTIONAL**
CORRELATIVE LABORATORY STUDY PARTICIPATION
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informed consent to participate in

Optional Correlative Laboratory Study Participation for patients enrolled on BMT CTN 1401 entitled "Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions"  
Your Name: __________________________  
Study Title: Optional Correlative Laboratory Study Participation for patients enrolled on BMT CTN 1401 "Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions"  
| Parent Study Title:      | Phase II Multicenter Trial of Single Autologous Hematopoietic Cell  Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma  with or without Vaccination with Dendritic Cell /Myeloma Fusions      |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Protocol:                | BMT CTN 1401 v4.0                                                                                                                                                                                               |
| Principal  Investigator: | Insert local PI information                                                                                                                                                                                     |
| Sponsor:                 | The National Institutes of Health (NIH) is sponsoring this study by  providing financial support for the coordination of this study through the  Blood and Marrow Transplant Clinical Trials Network (BMT CTN). |
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1. introduction

We invite you to participate in one or both of the optional correlative laboratory studies associated with the BMT CTN 1401 trial. You're being asked to join these optional studies because you were enrolled on BMT CTN 1401 and are being evaluated for randomization. Participation in these studies will involve you agreeing to allow investigators to either use previously collected research samples required by the primary trial and/or provide additional blood and marrow samples during your participation on the primary BMT CTN 1401 trial. It is your choice to participate in these optional studies and to provide additional blood or bone marrow samples for this optional research. Even if you decide not to participate in these optional research studies, you can still participate on the primary BMT CTN 1401 study.  
This Consent Form will tell you about the purpose of the optional research studies, the clinical samples needed for this research, the possible risks and benefits, other options available to you, and your rights as a research participant. Everyone who takes part in research at [insert facility name] should know that:
Being in any research study is voluntary.  
You will not directly benefit from being in the study. Knowledge we gain from this study may benefit others.  
If you give blood and bone marrow samples for research, you can change your mind at any time. The blood and marrow samples that you already provided will be used for research but no further research will be done after you change your mind.  
If you decide to quit the study, it will not affect your at [insert name of facility or institution].  
Please ask the study staff questions about anything that you do not understand, or if you would like to have more information.  
You can ask questions now or any time during the study. Please take the time you need to talk about the study with your doctor, study staff, and your family and friends. It is your decision to provide samples for research. If you decide to join, please sign and date the end of the Consent Form.
2. **Study Background**
The National Institutes of Health (NIH), through the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), are providing staff support and money for this research study. The BMT CTN and the NIH will make decisions about how to manage the study. For participation in one or both of these optional research studies, you will be asked to provide blood or bone marrow samples that will be shipped to a lab for further testing. Your doctor will discuss the research studies that are available to you as a part of this study.
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3. study purpose

We are conducting these additional laboratory studies to further our understanding and knowledge about how the treatments you receive as part of the parent study (BMT CTN 1401) work.
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4. rights to ask questions

You have the right to ask questions about the study at any time. If you have questions about your rights as a participant or you want to leave the study, please contact:
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[insert contact info]

Participating in either of these optional research studies is voluntary. You can choose not to be in these studies or leave either study at any time. However, some of the blood and bone marrow already donated may have already been used for research. If you choose not to take part or leave one of these studies, it will not affect your regular medical care in any way. Your study doctor and study staff will be available to answer any questions that you may have about taking part in or leaving these optional research studies.
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5. study treatment and tests

There are two different research studies associated with the primary parent trial (BMT CTN 1401) that you are participating in. You doctor will explain which studies you are being asked to participate on at the end of this consent form and you will be presented with one or two more informed consent forms. These consent forms will go over the study tests in detail. The schedule of blood or bone marrow collections will depend on which studies you agree to participate in. If you would like to participate in this optional research, you will be asked to sign this informed consent form along with the other consent form(s) associated with the optional research your doctor is asking you to be a part of. If you agree to participate on either of these research studies, your blood and or bone marrow will be shipped to laboratories at either Beth Israel Deaconess Medical Center and/or the University of Wisconsin. All research samples will be given a bar coded ID that cannot be linked to you by the researchers testing your samples. Samples will not be used for purposes other than those specified in this consent form.
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6. risks and discomforts

Information about your demographics, disease, and response to the treatments you receive as part of the main clinical study may be provided to the investigators listed in the privacy portion of this consent form. This information is used to help the investigators understand how the research samples correlate to your disease. There are no major risks to having your blood or bone marrow drawn. It can be uncomfortable to have your blood and bone marrow taken and it can sometimes leave a bruise. You might faint, but this is unlikely to happen. Only trained people will take your blood and bone marrow. A possible risk is the loss of confidentiality about your medical information. We will use safety measures with both your samples and clinical information to make sure that your personal information will be kept private. The chance that this information will be given to someone else is extremely small. For more information about risks and side effects, ask your study doctor.
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7. other treatments

Participation in this study is optional. The alternative to participating on this research sample study, is not agreeing to provide blood or bone marrow samples. If you choose not to take part, your treatment on BMT CTN 1401 will not be affected This information could help people with multiple myeloma who may need a transplant in the future
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8. possible benefits

Taking part in this study will not make your health better. You will not get any direct benefit from taking part in this study. The information from this study will help doctors and researchers learn more about how well unrelated transplant works as treatment for people with a blood disease.
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9. privacy confidentiality and use

Your privacy is very important to us. The study doctors will make every effort to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not identify who you are. Data regarding your clinical situation, including follow-up after 2 years, may be obtained from the CIBMTR, which captures information on all US transplants. All your medical and demographic information (such as race and ethnicity, gender and household income) will be kept private and confidential. *(Name of Transplant Center)* and the organizations listed below will not disclose your participation by any means of communication to any person or organization, except by your written request, or permission, or unless required by federal, state or local laws, or regulatory agencies.  
The individuals below will have access to your research and medical information. They may use this information for inspections or audits to study the outcomes of your treatment. By agreeing to participate, you consent to such inspections and to the copying of parts of your records, if required by these organizations. We may give out your personal information 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.  
Information about your transplant, research samples, and treatment on BMT CTN 1401 from your original medical records may be seen or sent to national and international transplant registries, including:
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1. /institution/

2. The Center for International Blood and Marrow Transplant Research (CIBMTR) 3. The National Marrow Donor Program (NMDP) 4. The Food and Drug Administration (FDA)  
5. The National Institutes of Health (NIH), which include the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI)
6. Data and Coordinating Center of the Blood and Marrow Transplant Clinical Trials Network
(BMT CTN)
7. Data and Safety Monitoring Board (DSMB), not part of /Institution/
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8. study investigators.

9. Dr. David Avigan and laboratory staff at Beth Israel Deaconess Medical Center/Dana Farber Cancer Institute 10. Dr. Fotis Asimakopoulos and laboratory staff at University of Wisconsin and at Medical College of Wisconsin.  
11. Celgene, the manufacturer of lenalidomide
DNA from your blood samples might be used in genome-wide association (GWA) studies for a future project either done or supported by the National Institutes of Health (NIH). Genome-wide association studies are a way for scientists to find genes that have a role in human disease or treatment. Each study can look at hundreds of thousands of genetic changes at the same time.  
If your coded samples are used in such a study, the researcher is required to add your test results and sample information into a shared, public research database. This public database is called the NIH Genotype and Phenotype Database and it is managed by the National Center for Biotechnology Information (NCBI). The NCBI will never have any information that would identify you, or link you to your information or research samples. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. For questions about access to your medical records, please contact /name/ at /number.
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10. ending your participation

The study doctor or the study sponsor may stop the study at any time, and we may ask you to leave the study. We may ask you to leave the study if you do not follow directions or if you suffer from side effects of the treatment. If we ask you to leave the study, the reasons will be discussed with you. Possible reasons to end your participation in this study include: 1. You do not meet the study requirements.  
2. The study doctor decides that it would be harmful to you to stay in the study. 3. You become unable to donate blood or bone marrow for any reason 4. The study is stopped for any reason.
Even if you leave the study, the information collected from your participation will be included in the study evaluation, unless you specifically ask that it not be included.
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11. physical injury as a

It is important that you tell your doctor, __________________ *[investigator's name(s)]* or study staff 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 __________________ *[telephone number]*. You will get all available medical treatment if you are injured from taking part in this study. You and/or your health plan will be charged for this treatment. There is no provision for free medical care or monetary compensation from the study sponsor, The National Institutes of Health or the study contributor, Celgene Corporation. In case you are injured in this study, you do not lose any of your legal rights to ask for or receive payment by signing this form.
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12. payment and study costs

You will not be paid for donating your blood and/or bone marrow.. You will not be paid or reimbursed for any extra expenses (travel, meals, etc.) you may have to donate blood and bone marrow. Your blood and marrow will be used only for research and will not be sold. The research done with your blood may help to develop new products in the future. You will not get paid for any samples or for any products that may be developed from current or future research. The visits for this research study are standard medical care for your autologous transplant and will be billed to your insurance company. You and/or your health plan/insurance company will need to pay for some or all of the costs of standard treatment in this study. For questions about your costs, financial responsibilities, and/or medical insurance coverage for your transplant and this study, please contact /Center/ Financial Counselor at /Number/.
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13. for more information

If you need more information about these studies, or if you have problems while taking part in either of these studies, you can contact the study doctor or his/her staff. They can be reached at the telephone numbers listed here:
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[insert name and contact details]

If you wish to speak to someone not directly involved in the study, or if you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact:
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[insert appropriate contact details]

The ethical aspects of this study have been reviewed and approved by *[name of IRB]*. Health Insurance Portability and Accountability Act 1 (HIPAA13) Authorization to use and disclose individual health information for research purpose
- **Purpose**:
As a research participant, I authorize the Principal Investigators and the researcher's staff to use and disclose my individual health information for the purpose of conducting either of the research studies described in this consent:
Optional Correlative Laboratory Study Participation for patients enrolled on *"Phase II*
Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions"
- **Individual Health Information to be Used or Disclosed**:
My individual health information that may be used or disclosed to do this research includes: 1. Demographic information (for example, date of birth, sex, weight). 2. Medical history (for example, diagnosis, complications with prior treatment). 3. Findings from physical exams. 4. Laboratory test results obtained at the time of work up and after transplant (for example, blood tests, biopsy results).  
- **Parties Who May Disclose My Individual Health Information**:
The researcher and the researcher's staff may collect my individual health information from:
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[list hospitals clinics or providers

- **Parties Who May Receive or Use My Individual Health Information**:
The individual health information disclosed by parties listed in item c and information disclosed by me during the course of the research may be received and used by the following parties:
1. Dr. David Avigan, Co-Principal Investigator 2. Dr. Nina Shah, Co-Principal Investigator 3. Dr. David Chung, Co-Principal Investigator 4. Laboratory staff at Beth Israel Deaconess Medical Center/Dana Farber Cancer Institute 5. Dr. Fotis Asimakopoulos and laboratory staff at University of Wisconsin and at Medical College of Wisconsin.  
6. Celgene, its collaborators or designees  
7. National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute
(NCI), both of the National Institutes of Health (NIH),
8. Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Data and Coordinating Center 9. U.S. government agencies that are responsible for overseeing research such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP)
10. U.S. government agencies that are responsible for overseeing public health concerns such as the Centers for Disease Control (CDC) and federal, state and local health departments.
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- right to refuse to

I do not have to sign this Authorization. If I decide not to sign the Authorization, I will not be allowed to participate in this study. My decision not to sign this authorization will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.
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- right to revoke

I can change my mind and withdraw this authorization at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw this authorization, the researcher may only use and disclose the protected health information already collected for this research study. No further health information about me will be collected by or disclosed to the researcher for this study.
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- potential for re-disclosure

My individual health information disclosed under this authorization may be subject to redisclosure outside the research study and no longer protected.  
Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures.
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- genetic information nondiscrimination act

A federal law (2009), called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information. Health insurance companies and group health plans may not request your genetic information that we get from this research. This means that they must not use your genetic information when making decisions regarding insurability. Be aware that this federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
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- this authorization does not

TITLE: Optional Correlative Laboratory Study Participation **for Patients Enrolled on BMT** CTN 1401 entitled, "Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with **Dendritic Cell /Myeloma Fusions"** PROTOCOL NUMBER: BMT CTN \#1401 PRINCIPAL INVESTIGATOR: Name:
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fax

I have read and understood this Consent Form. The nature and purpose of the research study has been explained to me.  
- I have had the chance to ask questions, and understand the answers I have been given. I
understand that I may ask questions at any time during the study.  
- I freely agree to be a participant in the study.
- I understand that I may not directly benefit from taking part in the study. - I understand that, while information gained during the study may be published, I will not be identified and my personal results will stay confidential.  
- I have had the chance to discuss my participation in this research study with a family member or friend.  
- I understand that I can leave this study at any time, and doing so will not affect my current care or prevent me from receiving future treatment.  
- I understand that I will be given a copy of this signed consent form.  
Participant Name Date  
 Signature Date  
Version 4.0 dated *July 24, 2018* I certify that I have provided a verbal explanation of the details of the research study, including the procedures and risks. I believe the participant has understood the information provided.  
| Name of Counseling Physician      | Date   |      |
|-----------------------------------|--------|------|
| Signature of Counseling Physician |        | Date |
table 2 treatment group a
supplemental informed consent form to

Study Title: Characterization of the T cell immune response and myeloma genomic signature as predictors of immunologic and clinical response Parent Study Title: Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions
table 2 treatment group a
a. what is this document?

The purpose of this document is to give you more information on the specific research sample study your physician is asking for your consent to join. This document will explain further details of what samples are collected, why they are being collected, and where they are being sent. Details about risks, study participation, and your rights are explained in the primary informed consent form that your doctor already presented to you.
table 2 treatment group a
b. why am i here?

You are being asked to participate in this study because you are participating on BMT CTN 1401 and are approaching the randomization portion of the parent study. If you give us your permission, we would like to collect extra samples of your blood and marrow at several time points during your participation on the parent trial.
table 2 treatment group a
c. why are you doing

We are collecting samples to learn more about how your body responds to the treatment on the parent trial. We will collect samples on 60 patients across all treatment arms. Your participation on this study is expected to last up to 3 years.
table 2 treatment group a
d. what will happen to

If you say you want to be in the study, we will ask you for the following samples:  
- Bone Marrow Aspirate Samples: About 1 teaspoon of bone marrow will be collected at the following timepoints:
o Just before you are randomized on the parent trial (about 50-80 days after your bone marrow transplant). This is one teaspoon more of bone marrow being collected at the time of a required bone marrow aspirate being performed as part of the primary trial.  
o Just before you start your 9th Cycle of Maintenance (about 1 year after your bone marrow transplant). This is one teaspoon more of bone marrow being collected at
the time of a required bone marrow aspirate being performed as part of the primary trial.  
o If your disease comes back, an additional bone marrow aspirate sample will be collected at that time. This is an additional aspirate not required as part of the primary trial.  
- Blood Samples:
o About 2 teaspoons of blood will be collected just before you start Cycles 1, 2, and 4 of Maintenance Therapy. This is extra blood being collected at the time of a required blood sample collection being performed as part of the primary trial.  
o If your disease comes back, about 10 teaspoons of blood will be collected at that time. This is an additional collection not required as part of the primary trial.  
- We will also use a portion of the bone marrow aspirate sample that you already provided at the time of agreeing to participate on the BMT CTN 1401 study as part of this research sample study.
table 2 treatment group a
e. where will my samples

Your samples will be sent to a laboratory at Beth Israel Deaconess Medical Center. All research samples will be tied to a number. This number will not be linked to your name or other identifying information.
table 2 treatment group a
statement of consent for research

The purpose of providing blood and bone marrow samples, the procedures involved, and the risks and benefits have been explained to me. I have asked all the questions I have at this time and I have been told whom to contact if I have more questions. I have been told that I will be given a signed copy of this consent form to keep. I understand that I do not have to allow the use of my blood and bone marrow for this research. If I decide to not let collect research samples now or in the future, it will not affect my medical care in any way. I voluntarily agree that my blood, bone marrow, and information can be used for the study entitled "Characterization of the T cell immune response and myeloma genomic signature as predictors of immunologic and clinical response". I also understand that my DNA and health information may or may not be used in genome-wide association studies. Signature Date
table 2 treatment group a
supplemental informed consent form to

Study Title: VCAN Proteolysis: Investigation of a Potential Novel Immune Biomarker in Myeloma Parent Study Title: Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions
table 2 treatment group a
a. what is this document?

The purpose of this document is to give you more information on the bone marrow sample study your physician is asking for your consent to join. This document will explain further details of what samples are collected, why they are being collected, and where they are being sent. Details about risks, study participation, and your rights are explained in the primary informed consent form that your doctor already presented to you. If you want to participate in this research you will be asked to sign the primary informed consent form as well as this document.
table 2 treatment group a
b. why am i here?

You are being asked to participate in this study because you are participating on BMT CTN 1401 and are approaching the randomization portion of the parent study. If you give us your permission, we would like to send a portion of a clinical bone marrow sample to study investigators at the time of randomization. The sample we are asking for is part of a clinical sample collection procedure you will have already undergone as part of the parent trial. We will not collect any additional samples as part of this study. We are asking for your consent to ship a portion of this clinical bone marrow sample to a different lab and study it for research purposes.
table 2 treatment group a
c. why are you doing

We are collecting bone marrow samples to learn more about how your body responds to the treatment on the parent trial. We will collect samples on 20 patients across all treatment arms. Your participation on this study is expected to last 1 month. We may use data collected on the parent trial for this study for up to 3 years after you are randomized on the parent trial.
table 2 treatment group a
d. what will happen to

The bone marrow sample we are asking for is part of a procedure you will already undergo as part of the parent trial. We will not collect any additional samples as part of this study. We are asking for your consent to ship a portion of this bone marrow sample to a different lab and study it for research purposes.  
If you say you want to be in the study, we will not collect any additional samples. The clinical pathology lab at /Institution/ will cut a small piece of your bone marrow biopsy that you provided for the BMT CTN 1401 parent trial and ship it to investigators at University of Wisconsin. If the lab is not able to obtain enough sample from the bone marrow biopsy you provided for the parent trial (BMT CTN 1401), you will not be asked to provide additional samples and you will be removed from the study.
table 2 treatment group a
e. where will my samples

Your samples will be sent to a laboratory at University of Wisconsin.  
All research samples will be tied to a number. This number will not be linked to your name or other identifying information.
table 2 treatment group a
statement of consent for research

The purpose of providing bone marrow biopsy samples, the procedures involved, and the risks and benefits have been explained to me. I have asked all the questions I have at this time and I have been told whom to contact if I have more questions. I have been told that I will be given a signed copy of this consent form to keep. I understand that I do not have to allow the use of my bone marrow biopsy samples for this research. If I decide to not let collect research samples now or in the future, it will not affect my medical care in any way. It will also not affect my participation in the Parent Trial. I voluntarily agree that my bone marrow biopsy samples and information can be used for the study entitled *"VCAN Proteolysis: Investigation of a Potential Novel Immune Biomarker in Myeloma"*. I also understand that my DNA and health information may or may not be used in genome-wide association studies. Signature Date APPENDIX C
LABORATORY PROCEDURES
appendix c laboratory procedures
collection of mandatory samples for

Bone marrow aspirate and peripheral blood will be collected for patients who consent to the BMT CTN 1401 study. Sample collection will be performed periodically throughout the study and will provide clinical samples required for: (1) DC/Myeloma fusion cell vaccine production and (2) correlative laboratory testing associated with critical immunologic study endpoints.  
**TC-DC/Myeloma Fusion Vaccine Production:** Upon enrollment on the BMT CTN 1401 study, all patients will have both peripheral blood and marrow aspirate samples collected, and delivered to the clinical center's cell processing facility for the isolation and storage of myeloma tumor cells as summarized in the table below. A sample of the processed myeloma tumor cells will be shipped to the BIDMC Central Laboratory for phenotypic characterization. For patients randomized to the cellular vaccine arm of the study, a therapeutic apheresis product will be collected and delivered to the clinical center's cell processing facility for the isolation of therapeutic cell dendritic cells (TC-DC) and the manufacturing of the TCDC/Myeloma fusion cell vaccine as summarized in the table below. A sample of the processed TC-DC cells and manufactured TC-DC/Myeloma fusion cell vaccine will be shipped to the BIDMC Central Laboratory for phenotypic characterization. And finally, additional samples of the manufactured TC-DC/Myeloma fusion cell vaccine will be shipped to Labs, Inc. Reference Laboratory for final product release sterility testing, endotoxin testing and mycoplasma screening.  
**Research Samples for Laboratory Correlatives Associated with Immunologic Endpoints:**
Required research samples for study-specific immunologic correlatives include the collection of blood and marrow aspirate samples as summarized in the table below (and in table 4.3B). The correlative studies include MRD Assessment, measurement of Plasmablast Response, NK Cell Reconstitution and the evaluation of Myeloma Reactive T-Cells. Once the samples are collected at specified time points they will be shipped on the day of collection directly to specified ancillary study laboratory for processing and testing. These samples will be tracked through GlobalTrace. Detailed procedures regarding specimen collection schedules, procedures and shipping instructions will be found in the BMT CTN 1401 Research Sample Information Guide.
appendix c laboratory procedures
collection of research samples associated

Additional marrow and/or peripheral blood samples, often linked to mandatory research sample collections for laboratory correlatives associated with protocol-defined immunologic endpoints, will be collected from patients who have agreed to participate in one or both of the optional laboratory studies described in Appendices J and K of this protocol. Sample collection will be done at the transplant center and will require minimum processing. Once the samples are collected at specified time points they will be shipped on the day of collection directly to specified ancillary study laboratory for processing and testing. The collection, processing and shipping of these biospecimens are summarized in the table below (and in table 4.3B). These samples will be tracked through GlobalTrace. Detailed procedures regarding specimen collection schedules, procedures and shipping instructions will be found in the BMT CTN 1401 Research Sample Information Guide.
appendix c laboratory procedures
- bone marrow aspirate or

o Patients participating in the VCAN Proteolysis Assessment **Study**: Once correlative study consent has been signed and patient has been randomized to one of the maintenance therapy arms of the trial, the clinical site will request 4 slides of decalcified marrow biopsy material to be made by the center's Clinical Pathology laboratory using stored paraffin blocks containing the processed clinical marrow tissue.  
o Patients participating in the **T Cell/Genomic Signature Study**: Once correlative study consent has been signed and patient has been randomized to one of the maintenance therapy arms of the trial, the clinical site will collect:
Additional 4 mL of marrow aspirate at two of the mandatory sample collection time points on the primary trial (1) at time of randomization, and (2) just prior to the initiation of cycle 9 of maintenance therapy.  
*Event Driven Sample Collection*: At disease progression collect 5 mL of marrow aspirate when possible.
appendix c laboratory procedures
- peripheral blood samples

o Patients participating in the **T Cell/Genomic Signature Study**: Once correlative study consent has been signed and patient has been randomized to one of the maintenance therapy arms of the trial, the clinical site will collect:
Additional 10 mL of peripheral blood at three of the mandatory sample collection time points on the primary trial: just prior to the initiation of cycles 1, 2 and 4 of maintenance therapy.  
*Event Driven Sample Collection*: At disease progression collect 40 mL of peripheral blood.
appendix c laboratory procedures
collection of optional samples for

Bone marrow aspirate and peripheral blood will be collected from patients who signed consent to provide additional samples for future research. Sample collection will be done at the transplant center and will require minimum processing. Once the samples are collected at specified time points they will be shipped on the day of collection to the BMT CTN Central Processing Laboratory for final processing and storage at the BMT CTN Research Repository. The collection, processing and shipping of these biospecimens are summarized in the table below (and in table 4.3B). These samples will be tracked through GlobalTrace. Detailed procedures regarding specimen collection schedules, procedures and shipping instructions will be found in the BMT CTN 1401 Research Sample Information Guide.
appendix c laboratory procedures
- bone marrow aspirate samples

Patients who consented for marrow sample collection for future research studies will have 3 mL of bone marrow aspirate collected at three time points (1) time of enrollment, (2) time of randomization, and (3) just prior to the initiation of cycle 9 of maintenance (~1 year post transplant)
appendix c laboratory procedures
- peripheral blood samples

Patients who consented for peripheral blood sample collection for future research studies will have 6 mL blood samples collected at three time points (1) time of enrollment, (2) following randomization onto the study, and (3) just prior to the initiation of cycle 9 of maintenance (~1 year post transplant)  
| Mandatory Research Samples & Testing Associated with TC-DC/Myeloma Fusion Vaccine Production                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                |                                               |                        |                 |          |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------|-----------------|----------|
| Purpose                                                                                                                                                                                                                                                                | Sample  Type                                                                                                                                                                                                                                                                                                   | Sample Collection Summary                     | Dates Samples Obtained | Cell Processing | Shipping |
| Laboratory                                                                                                                                                                                                                                                             | Location                                                                                                                                                                                                                                                                                                       |                                               |                        |                 |          |
| Bone marrow aspirates will be  collected using sodium-heparin  anticoagulant, following standard  institutional procedures and promptly delivered to the center's  cell processing facility for the  isolation and storage of myeloma  tumor cells.                    | Bone marrow aspirate sample  will be processed and myeloma  tumor cells stored for possible  future use for DC/Myeloma  cell fusion vaccine production.  Processing will be performed  according to protocol-specific  standardized procedures used  by all BMT CTN 1401 center  cell processing laboratories. |                                               |                        |                 |          |
| 30 mL                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                |                                               |                        |                 |          |
| Bone Marrow  Aspirate                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                |                                               |                        |                 |          |
| Myeloma Tumor  Cell Collection                                                                                                                                                                                                                                         | At time of enrollment for all study  patients                                                                                                                                                                                                                                                                  | Transplant  Center                            |                        |                 |          |
| Collect blood sample in five 10  mL fill green top plastic BD  Vacutainer® tubes, containing  Sodium-Heparin anticoagulant,  and promptly deliver to the  center's cell processing facility.                                                                           | Peripheral blood samples will  be processed and plasma  recovered for use in tumor cell  processing/storage as well as  subsequent DC/Myeloma  fusion cell vaccine  manufacturing steps.                                                                                                                       |                                               |                        |                 |          |
| Autologous  Plasma for  Vaccine  Production                                                                                                                                                                                                                            | 50 mL  Peripheral  Blood                                                                                                                                                                                                                                                                                       | At time of enrollment for all study  patients | Transplant  Center     |                 |          |
| 5-7 million processed myeloma  tumor cells in 3 mL tumor  media will be shipped at 2-8o C  by priority overnight FED EX  delivery to BIDMC Laboratory  for tumor lysate and  immunohistochemical staining.                                                             |                                                                                                                                                                                                                                                                                                                |                                               |                        |                 |          |
| 3 mL                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                |                                               |                        |                 |          |
| Processed  Myeloma  Tumor Cells                                                                                                                                                                                                                                        | BIDMC Central  Project  Laboratory                                                                                                                                                                                                                                                                             |                                               |                        |                 |          |
| Myeloma Tumor  Cell Phenotype  Characterization                                                                                                                                                                                                                        | No additional sample collection  needed from patient                                                                                                                                                                                                                                                           | N/A                                           |                        |                 |          |
| A therapeutic peripheral blood  apheresis product will be  collected following standard  institutional procedures and promptly delivered to the center's  cell processing facility for the  isolation of dendritic cells to be  used in cellular vaccine  preparation. | Apheresis products will be  processed and TC-Dendritic  cells recovered for  manufacturing the  DC/Myeloma fusion cell  vaccine. Processing will be  performed according to  protocol-specific standardized  procedures.                                                                                       |                                               |                        |                 |          |
| Peripheral  Blood  Therapeutic  Cells,  Apheresis  Product                                                                                                                                                                                                             |                                                                                                                                                                                                                                                                                                                |                                               |                        |                 |          |
| Isolation of  Therapeutic  Dendritic Cells                                                                                                                                                                                                                             | At time of randomization to only the  DC/Myeloma Vaccine arm of the  study                                                                                                                                                                                                                                     | Transplant  Center                            |                        |                 |          |  
| Mandatory Research Samples & Testing Associated with TC-DC/Myeloma Fusion Vaccine Production (continued)                                                                |                                                                                                                                                                                                                                                                                                                                                       |                                                      |                        |                 |          |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|-----------------|----------|
| Purpose                                                                                                                                                                 | Sample  Type                                                                                                                                                                                                                                                                                                                                          | Sample Collection Summary                            | Dates Samples Obtained | Cell Processing | Shipping |
| Laboratory                                                                                                                                                              | Location                                                                                                                                                                                                                                                                                                                                              |                                                      |                        |                 |          |
| 2-5 x 106 processed dendritic  cells in media will be shipped  at 2-8o C by priority overnight  FED EX delivery to BIDMC  Laboratory for  immunohistochemical staining. | BIDMC Central  Project  Laboratory                                                                                                                                                                                                                                                                                                                    |                                                      |                        |                 |          |
| TC– DC Cell  Phenotype                                                                                                                                                  |                                                                                                                                                                                                                                                                                                                                                       |                                                      |                        |                 |          |
| Characterization                                                                                                                                                        | Processed TCDendritic cells                                                                                                                                                                                                                                                                                                                                                       | No additional sample collection  needed from patient | N/A                    | 1-2 x 106 processed TCDC/Myeloma Fusion cells in  media will be shipped at 2-8o C  by priority overnight FED EX  delivery to BIDMC Laboratory  for immunohistochemical  staining.                 |          |
| TC-DC/Myeloma  Fusion Cell                                                                                                                                              | BIDMC Central  Project  Laboratory                                                                                                                                                                                                                                                                                                                    |                                                      |                        |                 |          |
| Processed TCDC/Myeloma  Fusion cells                                                                                                                                                                         | No additional sample collection  needed from patient                                                                                                                                                                                                                                                                                                  | N/A                                                  |                        |                 |          |
| Phenotype                                                                                                                                                               |                                                                                                                                                                                                                                                                                                                                                       |                                                      |                        |                 |          |
| Characterization                                                                                                                                                        | 2.0-5.0 x106 cells (fusion cell  vaccine) in 3 mL of media will  be shipped at ambient  temperature by priority  overnight FED EX delivery to  Labs, Inc., for product release  sterility testing.                                                                                                                                                    |                                                      |                        |                 |          |
| TC-DC/Myeloma  Fusion Cell  Vaccine                                                                                                                                     | 1 mL of fusion cell product  media will be shipped at 2- 8o C by priority overnight  FED EX delivery to Labs,  Inc. for endotoxin testing. Two sample aliquots, each  containing 0.5-1.0x106 cells  (fusion cell vaccine) in 0.5 mL  media will be shipped at 2-8o C  by priority overnight FED EX  delivery to Labs, Inc. for  Mycoplasma screening. |                                                      |                        |                 |          |
| Processed TCDC/Myeloma  Fusion cells                                                                                                                                                                         | Labs, Inc.  Reference  Laboratory                                                                                                                                                                                                                                                                                                                     |                                                      |                        |                 |          |
| No additional sample collection  needed from patient                                                                                                                    | N/A                                                                                                                                                                                                                                                                                                                                                   |                                                      |                        |                 |          |
| Final Release  Microbiological  Assessment                                                                                                                              |                                                                                                                                                                                                                                                                                                                                                       |                                                      |                        |                 |          |  
| Mandatory Research Samples Associated with Immunologic Study Endpoints                                                                                                                                                                               |                                                                                                                                                                                                                    |                           |                        |                         |                    |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------|-------------------------|--------------------|
| Purpose                                                                                                                                                                                                                                              | Sample  Type                                                                                                                                                                                                       | Sample Collection Summary | Dates Samples Obtained | Shipping Specifications | Shipping  Location |
| Collect bone marrow aspirated  sample and place 3 mL into each  of two green top plastic BD  Vacutainer® tube, containing  Sodium-Heparin anticoagulant.  Gently mix sample by inversion  8-10 times to mix sample well  with heparin anticoagulant. | One 3 mL bone marrow  aspirate sample will be shipped  at ambient temperature on the  day of collection to RPCI by  priority overnight FED EX  delivery for MRD assessment.                                        | RPCI                      |                        |                         |                    |
| Laboratory                                                                                                                                                                                                                                           |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Following randomization onto the  study; and following the completion  of cycle 9 of maintenance (~ 1 year  post transplant)                                                                                                                         |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| 6 mL                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Bone Marrow  Aspirate                                                                                                                                                                                                                                |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| MRD                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Assessment                                                                                                                                                                                                                                           | The remaining 3 mL bone  marrow sample will be sent to  the local pathology department  for MRD assessment.                                                                                                        | Transplant  Center        |                        |                         |                    |
| Collect bone marrow aspirated  sample and place into a green top  plastic BD Vacutainer® tube,  containing Sodium-Heparin  anticoagulant.                                                                                                            | Bone marrow aspirate sample  will be shipped at at 2-8o C on  the day of collection to BIDMC  by priority overnight FED EX  delivery.                                                                              |                           |                        |                         |                    |
| At time of enrollment, following  randomization onto the study; and  just prior to the initiation of cycle 9  of lenalidomide maintenance                                                                                                            |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| 4 mL                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Bone Marrow  Aspirate                                                                                                                                                                                                                                |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Myeloma                                                                                                                                                                                                                                              |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Reactive T Cells                                                                                                                                                                                                                                     | BIDMC Laboratory                                                                                                                                                                                                   |                           |                        |                         |                    |
| Collect blood sample and place  into three 10 mL fill green top  plastic BD Vacutainer® tubes,  containing Sodium-Heparin  anticoagulant. Gently mix sample  by inversion 8-10 times to mix  sample well with heparin  anticoagulant.                | For all patients: at time of                                                                                                                                                                                       |                           |                        |                         |                    |
| randomization; and 7 days after the  initiation of the 4th cycle (cycle 4+7)  of maintenance therapy.                                                                                                                                                | Blood sample tubes will be  shipped on the day of  collection at ambient  temperature, to the Wrammert  Laboratory at Emory  University by priority  overnight FED EX delivery.                                    |                           |                        |                         |                    |
| 30 mL  Peripheral  Blood                                                                                                                                                                                                                             | Emory  University Laboratory                                                                                                                                                                                       |                           |                        |                         |                    |
| Plasmablast  Response                                                                                                                                                                                                                                | Additional collections for patients in  the vaccine arm: immediately prior  the first dose of the vaccine (cycle  2) and 7 days later (cycle 2+7); and  immediately prior to the third dose  of vaccine (cycle 4). |                           |                        |                         |                    |
| Collect blood sample and place  into four 10 mL fill green top  plastic BD Vacutainer® tubes,  containing Sodium-Heparin  anticoagulant. Gently mix sample  by inversion 8-10 times to mix  sample well with heparin  anticoagulant.                 | Blood sample tubes will be  shipped at at 2-8o C on the day  of collection to BIDMC by  priority overnight FED EX  delivery.                                                                                       |                           |                        |                         |                    |
| 40 mL  Peripheral  Blood                                                                                                                                                                                                                             | At time of enrollment, and just prior  to initiation of cycles 1, 2, 3, 4, and  9 of maintenance.                                                                                                                  |                           |                        |                         |                    |
| Myeloma                                                                                                                                                                                                                                              |                                                                                                                                                                                                                    |                           |                        |                         |                    |
| Reactive T Cells                                                                                                                                                                                                                                     | BIDMC Laboratory                                                                                                                                                                                                   |                           |                        |                         |                    |  
| Mandatory Research Samples Associated with Immunologic Study Endpoints (continued)                                                                                                                                                   |                                                                                                                                                                                                                                                           |                                                                                                                                        |                        |                         |                    |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------|--------------------|
| Purpose                                                                                                                                                                                                                              | Sample  Type                                                                                                                                                                                                                                              | Sample Collection Summary                                                                                                              | Dates Samples Obtained | Shipping Specifications | Shipping  Location |
| Collect blood sample and place  into three 10 mL fill green top  plastic BD Vacutainer® tube,  containing Sodium-Heparin  anticoagulant. Gently mix sample  by inversion 8-10 times to mix  sample well with heparin  anticoagulant. | Immediately prior to initiation of  cycle 1 of maintenance; 7 days after  initiation of cycle 2 (cycle 2+7);  immediately prior to initiation of  cycle 3; 7 days after initiation of  cycle 4 (cycle 4+7); and just prior to  the initiation of cycle 9. | Blood sample tubes will be  shipped at ambient temperature  on the day of collection, to  MDACC by priority overnight  FED EX delivery |                        |                         |                    |
| 30 mL  Peripheral  Blood                                                                                                                                                                                                             |                                                                                                                                                                                                                                                           |                                                                                                                                        |                        |                         |                    |
| NK Cell                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                           |                                                                                                                                        |                        |                         |                    |
| Reconstitution                                                                                                                                                                                                                       | MDACC Laboratory                                                                                                                                                                                                                                          |                                                                                                                                        |                        |                         |                    |  
| OPTIONAL Undefined Future Research Sample Collections                                                                                                                                                                                 | Shipping  /Storage  Location                                                                                                                                                                                                                     |                                                                                                                                                                                                                              |                        |                         |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------|
| Purpose                                                                                                                                                                                                                               | Sample  Type                                                                                                                                                                                                                                     | Sample Collection Summary                                                                                                                                                                                                    | Dates Samples Obtained | Shipping Specifications |
| Collect bone marrow aspirated  sample and place into a green top  plastic BD Vacutainer® tube,  containing Sodium-Heparin  anticoagulant. Gently mix sample  by inversion 8-10 times to mix  sample well with heparin  anticoagulant. | Bone marrow aspirate tube will  be shipped at ambient  temperature on the day of  collection, to the BMT CTN  Research Repository by  priority overnight FED EX  delivery for processing and  final frozen storage of marrow  aliquots.          |                                                                                                                                                                                                                              |                        |                         |
| At time of enrollment, following  randomization onto the study, and just prior to the initiation of cycle 9  of maintenance                                                                                                           |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |
| 3 mL                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |
| bone marrow  aspirate                                                                                                                                                                                                                 | BMT CTN  Research  Repository                                                                                                                                                                                                                    |                                                                                                                                                                                                                              |                        |                         |
| OPTIONAL                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |
| Future Research                                                                                                                                                                                                                       | Collect blood sample in a  Red/Gray Top BD SST™ Tube  with Silica Clot Activator &  Polymer Gel. Let sample sit  upright in rack for 30-60 minutes.  Centrifuge for 10 minutes. Gel  barrier will form separating the  serum specimen from clot. | Serum blood tube will be  shipped at ambient temperature  on the day of collection, to the  BMT CTN Research  Repository by priority  overnight FED EX delivery for  processing and final frozen  storage of serum aliquots. |                        |                         |
| At time of enrollment, following  randomization onto the study, and just prior to the initiation of cycle 9  of maintenance                                                                                                           |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |
| 6 mL                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |
| peripheral  blood                                                                                                                                                                                                                     | BMT CTN  Research  Repository                                                                                                                                                                                                                    |                                                                                                                                                                                                                              |                        |                         |
| OPTIONAL                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |
| Future Research                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                              |                        |                         |  
| Research Samples Associated with Optional Correlative Laboratory Studies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                            |                                                                                                                                                            |                        |                         |                    |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------|--------------------|
| VCAN Proteolysis: Investigation of a Potential Novel Immune Biomarker in Myeloma (Appendix J)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                            |                                                                                                                                                            |                        |                         |                    |
| Purpose                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Sample  Type                                                                                                                                                                               | Sample Collection Summary                                                                                                                                  | Dates Samples Obtained | Shipping Specifications | Shipping  Location |
| Core bone marrow biopsy required  to be collected to confirm CR in a  subset of study patients prior to  randomization.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                            |                                                                                                                                                            |                        |                         |                    |
| 4 slides paraffinembedded,  decalcified  bone marrow biopsy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Slides of decalcified clinical  marrow biopsy material will be  made by the center's Clinical  Pathology laboratory using stored  paraffin blocks containing the  processed marrow tissue. | The 4 marrow biopsy slides  will be packaged and shipped  at ambient temperature to the  Asimakopoulos Laboratory by  priority overnight FED EX  delivery. | University of  WisconsinMadison  Laboratory                        |                         |                    |
| VCAN                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                            |                                                                                                                                                            |                        |                         |                    |
| Proteolysis  Assessment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | Slides will be requested once patient  is consented for this correlative  study and has been randomized to  an appropriate maintenance arm of  the 1401 trial.                             |                                                                                                                                                            |                        |                         |                    |
| Characterization of the T cell Immune Response and Myeloma Genomic Signature as Predictors of Immunologic and Clinical Response (Appendix K) Collect 4-5 mL bone marrow  aspirated sample (based on visit  requirements) and place into a  green top plastic BD Vacutainer® tube, containing Sodium-Heparin  anticoagulant. Gently mix sample  by inversion 8-10 times to mix  sample well with heparin  anticoagulant. 4 mL marrow collected at time of  randomization; and just prior to the  initiation of cycle 9 of maintenance  therapy. Bone marrow aspirate sample  will be shipped at 2-8o C on  the day of collection to the  BIDMC laboratory by priority  overnight FED EX delivery. 4-5 mL Bone Marrow  Aspirate BIDMC Laboratory EVENT DRIVEN SAMPLE: At disease progression collect 5 mL  of marrow when possible. T Cell/Genomic  Signature Study Collect blood sample and place  into 1-4 10 mL fill green top  plastic BD Vacutainer® tubes,  (based on visit requirements),  containing Sodium-Heparin  anticoagulant. Gently mix sample  by inversion 8-10 times to mix  sample well with heparin  anticoagulant. Collect 10 mL blood just prior to  initiation of cycles 1, 2, and 4 of  maintenance therapy. Blood sample tubes will be  shipped at 2-8o C on the day of  collection to BIDMC laboratory by priority  overnight FED EX delivery. 10-40 mL  Peripheral  Blood BIDMC LaboratoryEVENT DRIVEN SAMPLE: At time of disease progression,  collect 40 mL of blood. |                                                                                                                                                                                            |                                                                                                                                                            |                        |                         |                    |
appendix c laboratory procedures
appendix d

LENALIDOMIDE **RISKS OF FETAL EXPOSURE, PREGNANCY**
TESTING GUIDELINES AND ACCEPTABLE
BIRTH CONTROL METHODS
appendix d lenalidomide risks of
risks associated with pregnancy

Lenalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. An embryofetal development study in animals indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy. The teratogenic effect of lenalidomide in humans cannot be ruled out. Therefore, a risk minimization plan to prevent pregnancy must be observed. The use of lenalidomide in pregnant females and nursing mothers has not been studied nor has the effect of the lenalidomide on human eggs and sperm. The risks to a fetus are not known. However, because lenalidomide is related to thalidomide, and thalidomide is known to cause severe birth defects, the following requirements must be observed.  
Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and, 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed. Criteria for females of childbearing potential (FCBP) This protocol defines a female of childbearing potential as a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential)
for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
appendix d lenalidomide risks of
counseling

All counseling will be conducted through the Revlimid REMS program. For a female of childbearing potential, lenalidomide is contraindicated unless all of the following are met (i.e., all females of childbearing potential must be counseled concerning the following risks and requirements prior to the start of lenalidomide):
- She understands the potential teratogenic risk to the unborn child  
- She understands the need for effective contraception, without interruption, 28 days before starting study treatment, throughout the entire duration of study treatment, dose interruption and 28 days after the end of study treatment
- She should be capable of complying with effective contraceptive measures - She is informed and understands the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
- She understands the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test
- She understands the need and accepts to undergo pregnancy testing based on the frequency outlined in this protocol
- She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide The investigator must ensure that for females of childbearing potential:
- Complies with the conditions for pregnancy risk minimization, including confirmation that she has an adequate level of understanding
- Acknowledge the aforementioned requirements
For a female NOT of childbearing potential, lenalidomide is contraindicated unless all of the following are met (i.e., all females NOT of childbearing potential must be counseled concerning the following risks and requirements prior to the start of lenalidomide):  
- She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide
Traces of lenalidomide have been found in semen. Male patients taking lenalidomide must meet the following conditions (i.e., all males must be counseled concerning the following risks and requirements prior to the start of lenalidomide):  
- Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a female of childbearing potential
- Understand the need for the use of a condom even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a female of childbearing potential.
appendix d lenalidomide risks of
contraception

Females of childbearing potential (FCBP) enrolled in this protocol must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) during dose interruptions; and, 4) for at least 28 days after study treatment discontinuation.  
The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception:
Highly effective methods:
− Intrauterine device (IUD) − Hormonal (birth control pills, injections, implants)  
− Tubal ligation
− Partner's vasectomy Additional effective methods:
− Male condom  
− Diaphragm
− Cervical Cap
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended. If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. The efficacy *of contraceptive steroids may be* reduced during co-treatment with dexamethasone. Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia.
appendix d lenalidomide risks of
pregnancy testing

Medically supervised pregnancy tests with a minimum sensitivity of 50 mIU/mL must be performed for females of childbearing potential, including females of childbearing potential who commit to complete abstinence, as outlined below.
appendix d lenalidomide risks of
before starting study drug female

FCBP must have two negative pregnancy tests (minimum sensitivity of 50mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10 to 14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug (prescriptions must be filled within 7 days as required by the Revlimid REMS® program). The patient may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative.  
Male Patients:
Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
appendix d lenalidomide risks of
during study participation and for

Female Patients:
- FCBP with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following study drug discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following study drug discontinuation.  
- At each visit, the Investigator must confirm with the FCBP that she is continuing to use two reliable methods of birth control.  
- Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days.  
- If pregnancy or a positive pregnancy test does occur in a study patient, study drug must be immediately discontinued.  
- Pregnancy testing and counseling must be performed if a patient misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study treatment must be discontinued during this evaluation.  
- Females must agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation.
appendix d lenalidomide risks of
male patients

- Counseling about the requirement for complete abstinence or condom use during sexual contact with a pregnant female or a female of childbearing potential and the potential risks of fetal exposure to lenalidomide must be conducted at a minimum of every 28 days.  
- If pregnancy or a positive pregnancy test does occur in the partner of a male study patient during study participation, the investigator must be notified immediately.
appendix d lenalidomide risks of
additional precautions

- Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to the study doctor at the end of treatment.  
- Female patients should not donate blood during treatment and for at least 28 days following discontinuation of lenalidomide.  
- Male patients should not donate blood, semen or sperm during treatment or for at least 28 days following discontinuation of lenalidomide.  
- Only enough study drug for 28 days or one cycle of therapy (whichever is shorter) may be dispensed with each cycle of therapy.
appendix d lenalidomide risks of
appendix e

Revlimid REMS ® PROGRAM  
  
  
Revlimid Overview Revlimid REMS® for Study Participants Revlimid REMS® description:
A program that allows patients enrolled in authorized clinical trials access to free Revlimid® through the Revlimid REMS® program.  
Access to the Revlimid REMS **Program:** 1. All physicians must be registered prescribers of Revlimid® in the Revlimid REMS®
Program All clinical sites must have access to the Revlimid REMS® software to enroll patients in the Revlimid REMS® program 1) Prescriber submits Registration Form via fax or RevAssist® Online *(RAO* for Revlimid) to Celgene Customer Care.  
2) Prescriber is registered within 15 minutes. 3) Registration confirmation fax is sent to prescriber's office via fax. (For RAO, the confirmation notification is displayed on the screen immediately)
4) Starter Kit is sent to prescriber's office (overnight). The starter kit will contain the following:
- Instructions For Prescribers - Patient Resource Packs - Guide to English and Non-English Materials
- Computer software used to generate Patient-Physician Agreement Forms (PPAF)
2. **All studies must have an FDA letter of IND exemption or an active IND, active IRB approval**
and Celgene required regulatory documents.  
3. Patients must sign the research specific IRB-approved informed consent and be enrolled in a Celgene-approved Medical Affairs clinical trial using Revlimid®
4. **Celgene Customer Care Center must be contacted to confirm if a patient needs to be registered**
by calling 1-888-423-5436 5. Patients must also sign the appropriate PPAF form and follow all the procedures of the Revlimid REMS® Program 1) Patient and Prescriber complete the PPAF together.  
2) The form is faxed to Celgene Customer Care or submitted electronically through RAO.  
3) Patient is registered within 15 minutes. 4) Confirmation fax is sent to prescribing office notifying them that the patient is now registered. For RAO, the confirmation notification is displayed on the screen immediately.  
6. Patients and prescribers must take the phone surveys as required by the Revlimid REMS®
Program (The PPAF generated for the patient determines which phone survey questions
appendix d lenalidomide risks of
will be asked.) an authorization

Patient Survey requirements:
- For men: Do not need to call Celgene the first month but must call monthly starting the second month.  
- For females of non - child bearing potential: Must call for the first month and then call every 6 months after.  
- For females of child bearing potential: Must call for the first month and then every month after.
appendix d lenalidomide risks of
prescribing revlimid in the revlimid

- Celgene Medical Affairs Operations will activate the study with Biologics upon receipt of all required regulatory documents.  
- Biologics will not dispense or ship Revlimid® prior to Celgene's notification of activation. - Prescription information MUST BE entered using the BMT CTN 1401 **Revlimid REMS®**
study specific electronic prescription form. This form can be found on the BMT CTN
SharePoint website (https://bmtctnsp.net)
- **An authorization number** must be on the prescription form at the time of faxing.  
- Prescriptions for Revlimid® must be sent to Biologics Clinical Trial Division at the following FAX number: 919-256-0794
- Only a 28-day supply of Revlimid® may be provided per cycle sent to the actual address noted on the Revlimid REMS® **electronic study specific prescription form.**
- **Biologics will verify the authorization number** and complete the patient counseling.
appendix d lenalidomide risks of
protocol compliance and drug return

- Patients will be required to return unused drug to the study site for destruction per institutional guidelines.  
- Sites may request that patients maintain a diary and/or to bring their bottles in for a pill count at each visit in order to review "patient compliance."
important information about revlimid rems
protocol compliance and drug return

- To avoid fetal exposure REVLIMID®(lenalidomide) is only available under a special restricted distribution program called Revlimid REMS®
- Only prescribers registered with Revlimid REMS® can prescribe REVLIMID®(lenalidomide)  
- Only Revlimid REMS® contract pharmacies can dispense REVLIMID®(lenalidomide)
- In order to receive REVLIMID® (lenalidomide), patients must enroll in Revlimid REMS® and agree to comply with the requirements of the Revlimid REMS® program
- Information about REVLIMID®(lenalidomide) and the Revlimid REMS® program can be obtained by calling the Celgene Customer Care Center toll-free at 1-888-423-5436, or at www. REVLIMID.com