Clinical trial: NCT04552743
Section: Alternatives
Subsections: Alternatives

IRB Use Only  
  
  
Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma Participant ID:
You may chose to undergo stem cell mobilization and collection with alternative strategies that are available. Two common strategies include:
Clinical trial: NCT04552743
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Obtained, Used Or Disclosed?|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?|When Will My Authorization Expire?

The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified.  
  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma The purpose of this research study is to obtain information on the safety and effectiveness of MGTA-145. The data and information regarding your participation in this study will be provided to Magenta Therapeutics, the company who is providing the drug. In addition information may be provided to the Food and Drug Administration and other federal and regulatory agencies as required.  
Participant ID:
Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction. This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by the National Center for Advancing Translational Sciences which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of such as child abuse and neglect, or harm to self or others.  
IRB Use Only Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma Participant ID:
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document. Please refer to the section entitled "What Personal Information Will Be Obtained, Used or Disclosed?".  
IRB Use Only Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma Participant ID:

Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.

Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to demographics, medical history, physical examination findings, myeloma diagnosis, treatment and response, laboratory reports include blood/urine tests and pathology reports, imaging reports, reports of procedures including echocardiogram and lung function tests and medical history.

The following parties are authorized to use and/or disclose your health information in connection with this research study:
- The Protocol Director (Surbhi Sidana, MD)
- The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
- Research Staff

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
Page 18 of 23 IRB Use Only Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma  
- The Office for Human Research Protections in the U.S.  
Department of Health and Human Services
- Magenta Therapeutics
- The United States Food and Drug Administration - National Institutes of Health
Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.

Your authorization for the use and/or disclosure of your health information will end on December 31, 2045 or when the research project ends, whichever is earlier.  
________________________________ ______________
Signature of Adult Participant Date
________________________________
Print Name of Adult Participant
_______________________________ ______________ Signature of Legally Authorized Representative (LAR) Date
(e.g., parent, guardian or conservator) ________________________________
Print Name of LAR ________________________________________________________
LAR's Authority to Act for Participant
(e.g., parent, guardian or conservator)  
  
IRB Use Only Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma Payment/Reimbursement You will not be paid to participate in this research study.  
Participant ID:
Clinical trial: NCT04552743
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

This research study is expected to take approximately 24 months to recruit all participants and report results. Your active participation in the study including the medicines for cell mobilization, apheresis, clinic visits or phone calls is for a duration of two to six months. If you are scheduled for transplant within two months of stem cell collection, we will see you in clinic and call you on the phone for up to four months after your transplant. If you are NOT planning a transplant within two months of collecting your stem cells, we will follow you for up to one month after stem cell collection, including clinic visits/phone calls.  
Participant ID:
This research study is looking for 25 people with multiple myeloma who need stem cells collected for autologous stem cell transplantation. At this time, this study is only open at Stanford University. After the active follow-up period, which includes clinic visits/phone calls, we may continue to collect information on your health status, myeloma treatment and transplant history from your electronic medical record periodically, whichever is later. If these stored stem cells are shipped to another medical center for a stem cell transplant, we will request that center send us medical records about your stem cell transplant after getting your authorization to do so.  
  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma If you choose to participate, Surbhi Sidana, MD, the Protocol Director and her research study staff will consent you to the study. The study is divided into three phases:
Clinical trial: NCT04552743
Section: Participant's Rights
Subsections: Participant'S Rights

You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director. You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.
Clinical trial: NCT04552743
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, **Discomforts, And Inconveniences**

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions.
Clinical trial: NCT04552743
Section: Procedures
Subsections: 1. **Pre-Mobilization Phase:**|Procedures|Table 1: Study Medicines And Stem Cell Collection Procedures

After you sign informed consent, you will have a physical examination, blood tests and other tests that are routinely done before stem cell collection and transplant per Stanford University BMT Division's guidelines and standard practices. The study team will review the results of these tests, as well as review your medical history and myeloma treatment history to determine whether you are eligibile to participate in the study and proceed with stem cell mobilization.  
2. **Mobilzation phase:** This phase of the study is the only phase which involves the investigational/experimental medicine. A summary is provided in **Table 1.**
Participant ID:

On your scheduled day of stem cell mobilization, you will receive plerixafor injection under the skin (subcutaneously), followed two hours later by MGTA-145, which is given by vein (IV - intravenously) over 3 to 10 minutes. A few minutes after that you will start the stem cell collection procedure/ apheresis, which will last at least 4.5 hours and may last up to 6-7 hours depending on your height and weight. Our goal is for the machine to circulate and process your entire blood volume at least three times to collect enough stem cells. Apheresis or stem cell collection is done through a peripheral intravenous catheter (small plastic tube in your arm) or a central line, which is a intravenous line placed in your neck. The decision regarding the type of approach used for stem cell collection is made by your treating physician and the apheresis team. Participation in this study will not impact the choice of catheter used for apheresis. You will have at least three blood samples drawn on each day of mobilization/stem cell collection. The first sample will be collected in the  
  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma morning, the second one will be collected approximately 15-30 minutes after MGTA-145 infusion and the third at the end of apheresis. Additional samples may be collected if anything is not normal. This is according to Stanford BMT standard guidelines and is not specific to this research. We will also ask you questions about side effects you have and ask you to fill out questionnaires on each day of stem cell collection and in the followup clinic visit after stem cell collection. These questionnaires pertain to side effects, pain and quality of life during collection. The stem cells collected will be processed per Stanford BMT/Cell Therapy Facilty standard procedures for evaluating the stem cell count and for cryopreservation i.e storage under very cold temperatures. This is done for all stem cell collections in patients with myeloma. A part of the collected stem cell product, about 15 mL will be stored for research purposes. The goal of these research tests is to understand the nature and effectiveness of the stem cells collected with this new technique and other cells or components that are present in the collected stem cell product.  
| Medication/Procedure                 | Day 1                                                                                                                                                   | Day 2 (If  needed)   |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Plerixafor                           | One dose given subcutaneously                                                                                                                           | Same as day 1        |
| MGTA-145 (Investigational  medicine) | One dose given as an intravenous  infusion over 3 to 10 minutes. This will  be given 2 hours after plerixafor.                                          | Same as day 1        |
| Apheresis procedure to               | At least 4.5 hours and can last upto 6-                                                                                                                 |                      |
| collect stem cells                   | 7 hours depending on your height and  weight. Remaining details of this  procedure will be per Stanford  University BMT division's standard  practices. | Same as day 1        |
| Questionnaire asking                 | After receiving MGTA-145                                                                                                                                | Same as day 1        |
| about symptoms                       | Page 6 of 23                                                                                                                                            |                      |
| Participant ID:                      |                                                                                                                                                         |                      |

IRB Use Only Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma  
Participant ID:  
Blood Samples At least three blood samples:  
| Blood Samples                                                                                                                                                                                                                                      | At least three blood samples:   | Same as day 1   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------|
| Before receiving plerixafor for routine  blood work (standard practice) After receiving MGTA-145 to check  CD34 count (research) After stem cell collection to check  CD34 count (research) Additional samples as clinically needed  for your care |                                 |                 |
Clinical trial: NCT04552743
Section: Purpose of Research
Subsections: Purpose Of Research|What Is The Purpose Of This Research Study And How Will My Health Information Be Utilized In The Study?

You were selected as a possible participant in this study because you have multiple myeloma and are being considered for an autologous stem cell transplant, either in the immediate future or later in your disease course. To prepare for the transplant we need to collect special cells called 'hematopoetic stem cells'.  
Participant ID:
to let your bone marrow recover before having another stem cell mobilization and apheresis procedure. All of the cells of the immune system including red cells, white cells and platelets are made in the bone marrow. All of these cells develop from a type of cell found in the bone marrow called a "hematopoietic stem cell." This is the type of cell collected for blood and marrow transplantation. In order to collect enough hematopoietic stem cells from the bone marrow to make a successful transplant, we have to move the cells from the bone marrow to the blood. Once they are in the blood, they can be collected during a procedure called 'apheresis'. Currently this requires several days of different medicines (4-5 days) and several days of apheresis. In this study you will be given an investigational medicine (MGTA-145) in combination with an FDA approved medicine called plerixafor. Currently plerixafor given with granulocyte colony stimulating factor or G-CSF is the procedure approved by the FDA for stem cell collection. In this study you will not receive G-CSF.  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma We hope to learn whether the combination of MGTA-145 and plerixafor, given on the same morning as stem cell collection for up to two days, allows us to collect enough stem cells to do an autologous stem cell transplant. We will also evaluate the side effects of this new medicine combination and whether there is any effect on the transplant, including engraftment (the repopulation of normal blood cells with the infused stem cells) and myeloma response, for up to three months after your transplant. We will also ask you questions about your pain and how you are feeling after receiving the MGTA-145 and plerixafor. If you consent to participate in this study, the study team will review your treatment history and results of laboratoty tests and other tests ordered by your transplant doctor as part of your transplant evaluation. This is to determine whether you meet the criteria to receive MGTA-145.  
Participant ID:
The MGTA-145 is being provided by Magenta Therapeutics, the study medicine's manufacturing company and will be provided to you at no charge. If you meet the criteria, you will first be given plerixafor as a shot or injection under the skin, followed 2 hours later by the investigational study drug (MGTA145), which is given as an intravenous (IV) infusion (into a vein in your arm). This infusion will take up to ten minutes. Following MGTA-145, you will start the stem cell collection procedure (apheresis). This procedure will last at least 4.5 hours and up to 6 to 7 hours, depending on your height and weight. Your blood will be drawn through a needle in your arm or through a central venous catheter (CVC) and will then pass through an apheresis machine, which identifies stem cells by targeting a marker on them called CD34. The medicines and apheresis may be repeated the next day depending on the number of stem cells collected. The goal is to collect at least 2 million CD34+ stem cells/kg of your body weight in two days.  
If enough cells are not collected on these two days, your physician may ask you to use another method for mobilizing stem cells after after you have a rest. You can decide to stop participation at any time during this study. If you decide to stop participating in this study, you should notify Surbhi Sidana, MD 300 Pastuer Drive H0101c Stanford, CA 94305 Phone Number: 650-723-0822 Email: surbhi.sidana@stanford.edu  
  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma After one to two days of MGTA and plerixafor followed by stem cell collection, you will not receive any further investigational agent. The remainder of the procedures, including transplant will be done according to Stanford University Blood and Marrow Transplantation (BMT) Division's standard institutional practice.

This is a clinical trial studying a new drug called MGTA-145 in combination with plerixafor to collect stem cells in prepeparation for autologous stem cell transplant in multiple myeloma. Results of this study, which includes de-identified patient information about how well this combination worked, side effects, treatment history and outcomes with transplant will be reported in scientific presentations and publications. The information will also be submitted to Magenta Therapeutics, which is providing the drug, and the FDA.
Clinical trial: NCT04552743
Section: Voluntary Participation
Subsections: Voluntary Participation|Do I Have To Sign This Authorization Form?

Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.

You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study including receiving any research-related treatment. Signing the form is not a condition for receiving any medical care outside the study.
Clinical trial: NCT04552743
Section: Withdrawal from Study
Subsections: Withdrawal From Study|If I Sign, Can I Revoke It Or Withdraw From The Research Later?

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled. If you decide to withdraw your consent to participate in this study, you should notify Surbhi Sidana, MD at 650-723-0822 with a verbal request to withdraw from the study or submit a verbal or written request to the study team or your Stanford BMT doctor. If you withdraw from the study before stem cell collection, no treatment with MGTA-145 will be given. Your team will continue your routine clinical care  
Participant ID:
Identifiers might be removed from identifiable private information and/or identifiable specimens and, after such removal, the information and/or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.  
- Follow the instructions of the Protocol Director and study staff. - Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
- Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
- Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.  
- Complete your questionnaires as instructed. - Ask questions as you think of them. - Tell the Protocol Director or research staff if you change your mind about staying in the study.
IRB Use Only  
  
Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma Participant ID:
The Protocol Director may also withdraw you from the study and the study medication may be stopped, without your consent for one or more of the following reasons:
o Failure to follow the instructions of the Protocol Director and study staff.  
o The Protocol Director decides that continuing your participation could be harmful to you.  
o You need treatment not allowed in the study, include need for stem cell mobilization with other treatments.  
o The study is cancelled.  
o Other administrative reasons.  
o Unanticipated circumstances.

If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study)
Page 17 of 23 IRB Use Only Approval Date: August 17, 2021 Expiration Date: August 17, 2022  
Protocol Title: Phase II Study of MGTA-145 in combination with plerixafor in the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma Surbhi Sidana, MD
300 Pastuer Drive H0101c Stanford, CA 94305 Phone Number: 650-723-0822 Participant ID:
at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: