Clinical trial: NCT02728102
Section: Confidentiality
Subsections: 10. Privacy, Confidentiality And Use Of Information|- Individual Health Information To Be Used Or Disclosed:|[List Hospitals, Clinics Or Providers From Which Health Care Information Can Be Requested]. - Parties Who May Receive Or Use My Individual Health Information:|- Potential For Re-Disclosure:|- Potential For Re-Disclosure:|- Genetic Information Nondiscrimination Act (Gina)|- Genetic Information Nondiscrimination Act (Gina)|9. Privacy, Confidentiality And Use Of Information|[List Hospitals, Clinics Or Providers From Which Health Care Information Can Be Requested].|- Potential For Re-Disclosure:|- Potential For Re-Disclosure:|- Genetic Information Nondiscrimination Act (Gina)|- Genetic Information Nondiscrimination Act (Gina)|- This Authorization Does Not Have An Expiration Date.

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:

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:

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.

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.

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.

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: Name:

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.

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:

- **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.

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.

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.

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: Name:

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.

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:
Clinical trial: NCT02728102
Section: Participant Responsibilities
Subsections: Making Your Choice|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples|Statement Of Consent For Research Samples

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.

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.

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

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.

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.

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

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.

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.

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

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.
Clinical trial: NCT02728102
Section: Participant's Rights
Subsections: Table 1. Study Treatment Groups|[Insert Name And Contact Details] 16. Contact Someone About Your Rights|You Can Change Your Mind At Any Time About Allowing Us To Use Your Samples And Health Information For Research.|- Right To Revoke:|- Right To Revoke:|4. Rights To Ask Questions And/Or Withdraw|4. Rights To Ask Questions And/Or Withdraw|[Insert Name And Contact Details] 14. Contact Someone About Your Rights|- Right To Refuse To Sign This Authorization:|- Right To Revoke:|- Right To Revoke:

| Treatment Group A  (maintenance treatment with  GM-CSF and vaccines)   | Treatment Group B  (maintenance treatment with  GM-CSF)   | Treatment Group C (only  maintenance treatment)   |                                       |           |                       |              |
|------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------|---------------------------------------|-----------|-----------------------|--------------|
| -                                                                      | Melphalan                                                 | (chemotherapy                                     |                                       |           |                       |              |
| drug)                                                                  | -                                                         | Melphalan  (chemotherapy drug)                    | -                                     | Melphalan | (chemotherapy         |              |
| drug)                                                                  |                                                           |                                                   |                                       |           |                       |              |
| -                                                                      | Autologous transplant                                     | -                                                 | Autologous transplant                 | -         | Autologous transplant |              |
| -                                                                      | Lenalidomide (maintenance  treatment)                     | -                                                 | Lenalidomide  (maintenance treatment) | -         | Lenalidomide          | (maintenance |
| treatment)                                                             |                                                           |                                                   |                                       |           |                       |              |
| -                                                                      | GM-CSF                                                    | -                                                 | GM-CSF                                | -         |                       |              |
| -                                                                      | Vaccine                                                   |                                                   |                                       |           |                       |              |  
This study will help doctors make the best choice about treatment after transplant for patients with MM. See section **5: Study Tests and Treatments** for information on how your treatment group will be determined and for information about the drugs listed in **Table 1**.

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:

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.

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.

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.

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:

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:

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:

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.

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.

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.
Clinical trial: NCT02728102
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. Risks And Discomforts|6. Risks And Discomforts|Risks Of Making The Vaccine|Risks Of Medications|Risk To The Unborn|Reproductive Risks|Females Who Join The Study|Males Who Join The Study|Damage To The Vital Organs In Your Body|Relapse (Return) Of Disease Or A New Blood Cancer|All Patients Taking Lenalidomide|Other Risks Serious Infections|Unforeseen Risks|12. Physical Injury As A Result Of Participation|6. Risks And Discomforts|6. Risks And Discomforts|11. Physical Injury As A Result Of Participation

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.

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.

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.

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)                      |                                                                         |                                           |                                  |               |                   |      |  
Melphalan - **Conditioning Regimen Drug (Before Transplant)**

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.
Clinical trial: NCT02728102
Section: Procedures
Subsections: Before You Start Your Treatment|During Your Treatment Tumor Cell Collection|Initial Treatment For Multiple Myeloma (Mm)|Conditioning Regimen Before Transplant|Infusion Of Blood Forming Cells (Transplant)|Maintenance Treatment Dose (All Treatment Groups) How We Will Give You Lenalidomide|How To Take The Lenalidomide Pills|Checking Your Health|Blood And Bone Marrow Samples|D. What Will Happen To Me If I Join The Study?|D. What Will Happen To Me If I Join The Study?|D. What Will Happen To Me If I Join The Study?|D. What Will Happen To Me If I Join The Study?

You will need to have several check-ups and tests to see if you can be in the study. These checkups and tests are part of your regular cancer care and would be done even if you were not part of this study. These tests include:  
- Medical history and physical exam
- Blood tests for cell counts
- Liver and kidney function tests
- Tests to measure your disease
- Bone marrow tests - Skeletal survey
- A pregnancy test (if you are a woman able to have children)

After you join the study, we will collect about 30mL (approximately 2 tablespoons) of bone marrow and 50mL (approximately 3 tablespoons) of blood. The bone marrow and blood samples will be frozen until it is determined if you will receive the vaccine as part of your treatment. This tumor cell collection is not part of your standard of care treatment If you are assigned to Treatment Group A after your transplant, your bone marrow will be thawed and used to make your vaccine. If you are assigned to Treatment Group B or C, your bone marrow sample will not be used in this study. Your doctor may talk to you about other uses for your stored bone marrow samples not related to this study. We will also talk with you about giving extra blood and marrow samples for future research (see section **17: Blood and Marrow Samples for Future Research**). The extra blood and marrow samples are also completely optional.

The first step (initial) is standard chemotherapy treatment (chemo). Chemo lowers the number of MM cells in your body. Different chemotherapy drugs can be used to treat MM. Your doctor will decide which drug or combination of drugs is best for you. You will be asked to sign a separate consent form that will explain the side effects of whichever drug your doctor chooses. This step may last several months.

The third step is the conditioning regimen, or the chemotherapy, you will get before your transplant. The conditioning regimen helps the blood-forming cells start to grow and make new cells in your bone marrow (engraft). The regimen includes a chemo drug called **melphalan**,
given by intravenous infusion (IV) in your arm. Your doctor will decide when you are ready to get melphalan. You will start this treatment step no more than 12 months after you start on this study. Melphalan works better for some patients than it does for others. If the drug does not work well for you, you may not be able to have a transplant. Your doctor will talk to you about other treatment options.

On your transplant day (Day 0), your cells will be given to you through your catheter. The cells will travel to your bone marrow where they will start to make healthy, new blood cells (engraft).

Lenalidomide is available only from a certified pharmacy through the Revlimid REMS® program. During maintenance therapy, only a 28-day supply (1 cycle) will be given to you at a time. If this is the first time you've taken lenalidomide, you'll have to sign-up, or register, for the program. This will include a separate consent process, which calls out the reproductive risks of taking this medicine. You'll have to give your name, address, phone number, birth date, and social security number to sign-up for the program. This information will be provided to Celgene Corporation and Biologics Incorporated to show you're taking part in this study. After you're registered, you'll be counseled at the site or through the program:
- When you're first given the drug
- At least every 28 days while you're taking it, and
- When you stop taking it You will be counseled about:
- Side effects  
- Not sharing lenalidomide (or other study drugs)
- Risks of exposing a fetus (unborn baby)
- Donating blood
- How to take the pills
We'll give you the, "Lenalidomide Information Sheet for Patients Enrolled in Clinical Research Studies" with each new supply of lenalidomide to remind you of these safety issues.

- Swallow the whole lenalidomide pill with water at the same time each day. Do not break, chew or open the capsules.  
- If you miss a dose, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do not take a double dose to make up for the missed dose).  
- If you take more than the prescribed dose you should seek emergency medical care if needed and contact study staff right away.  
- Women who can become pregnant that care for you should wear gloves whenever they need to touch the lenalidomide pills or bottles.

We will watch your health closely during your maintenance treatment, including how well your organs work. We will lower your dose if your organs don't handle the treatment well. We won't start a new cycle until your organs work well again. If we lower your dose and then your organs start working normally, we may raise your dose again. We will stop the maintenance treatment if you:
- Have a serious side effect
- Have low blood cell counts - Are a woman and become pregnant, or there is a chance that you are pregnant
- Go more than 56 days before starting a new maintenance treatment cycle - Don't follow the study directions, or - Choose to leave the study.  
You will need to visit your clinic for several check-ups and tests during your maintenance treatment. These tests are shown in **Table 4. These assessments are standard of care for**
patients receiving lenalidomide maintenance therapy.  
| Timeline for Maintenance Treatment Tests (CYCLES)                     | Timeline for   |    |    |    |    |    |    |    |    |    |    |    |    |     |
|-----------------------------------------------------------------------|----------------|----|----|----|----|----|----|----|----|----|----|----|----|-----|
| Post-Transplant  Tests (Months)                                       |                |    |    |    |    |    |    |    |    |    |    |    |    |     |
| Before  you're  Random ized                                           |                |    |    |    |    |    |    |    |    |    |    |    |    |     |
| Tests                                                                 | 1              | 2  | 3  | 4  | 6  | 9  | 12 | 15 | 8  | 21 | 24 | 6T | 2T | 24T |
| Physical  exam, height,                                               | X              | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  | X   |
| and weight Tests for  toxicities, and                                 | X              | X  | X  | X  | X  | X  | X  | X  | X  | X  |    |    |    |     |
| infections Blood tests for  cell counts,  liver and  kidney  function | X              | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  |    |     |
| Tests to see  how much  cancer you  still have                        | X              | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  |    |     |
| Pregnancy test  (women able  to have  children)                       | X              | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  | X  |    |     |

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.  
| Maintenance Cycles                                  |                |         |         |      |      |      |        |     |
|-----------------------------------------------------|----------------|---------|---------|------|------|------|--------|-----|
| When  you join  the  study                          | 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                                     |                |         |         |      |      |      |        |     |  
Table 5: Timeline and Sample Amount Collected during Study (in approximate tablespoons (Tbsp) or teaspoons (tsp))

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.

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.

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.

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.
Clinical trial: NCT02728102
Section: Purpose of Research
Subsections: - Purpose:|- Purpose:|- Purpose:|- Purpose:|C. Why Are You Doing This Study?|C. Why Are You Doing This Study?|C. Why Are You Doing This Study?|C. Why Are You Doing This Study?

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

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:

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

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:

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.

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.

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.

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.
Clinical trial: NCT02728102
Section: Withdrawal from Study
Subsections: 11. Ending Your Participation|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. 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.

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.