Clinical trial: NCT04205240
Section: Alternatives
Subsections: 8. What Other Choices Do I Have If I Do Not Take Part In The Study?

Taking part in this research study is voluntary. Instead of being in this research study, you have other options which may include the following:  
Taking part in another research study, if one is available Receiving standard of care treatment Receiving comfort care, also called palliative care. This type of care may help to reduce the symptoms caused by cancer, but does not treat the cancer directly Receiving no treatment
You may choose not to participate without penalty or loss of benefits to which you are otherwise entitled.
Clinical trial: NCT04205240
Section: Confidentiality
Subsections: 13. Will My De-Identified Information Be Used Or Shared For Future Research? No 14. Will My Study-Related Information Be Kept Confidential?|15. Hipaa Authorization To Use And Disclose Information For Research Purposes|Iii.Who Might Get This Information?|Iv. Your Information May Be Given To:|Vi. When Will My Permission End?

Efforts will be made to keep your study-related information confidential. However, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law.  
Also, your records may be reviewed by the following groups (as applicable to the research):
Office for Human Research Protections or other federal, state, or international regulatory agencies; U.S. Food and Drug Administration; The Ohio State University Institutional Review Board or Office of Responsible Research Practices; Your insurance company (if charges are billed to insurance).
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search the website at any time by entering the NCT number NCT04205240.

I. **What information may be used and given to others?**
Past and present medical records; Research records; Records about phone calls made as part of this research; Records about your study visits; Information that includes personal identifiers, such as your name, or a number associated with you as an individual; Information gathered for this research about:
HIV / AIDS Hepatitis infection Sexually transmitted diseases Other reportable infectious diseases Physical exams Laboratory, x-ray, and other test results Diaries and questionnaires The diagnosis and treatment of a mental health condition Records about any study drug you received;

The sponsor of this research. "Sponsor" means any persons or companies that are:
working for or with the sponsor; or owned by the sponsor.  
Authorized Ohio State University staff not involved in the study may be aware that you are participating in a research study and have access to your information; If this study is related to your medical care, your study-related information may be placed in your permanent hospital, clinic, or physician's office record.

The U.S. Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) agencies, and other federal and state entities; Governmental agencies in other countries; Governmental agencies to whom certain diseases (reportable diseases) must be reported; and The Ohio State University units involved in managing and approving the research study including the Office of Research and the Office of Responsible Research Practices.  
V. **Why will this information be used and/or given to others?**
To do the research; To study the results; and To make sure that the research was done right.

There is no date at which your permission ends. Your information will be used indefinitely. This is because the information used and created during the study may be analyzed for many years, and it is not possible to know when this will be complete.
Clinical trial: NCT04205240
Section: Duration of Study Involvement
Subsections: Before You Begin The Study Screening Assessments Performed Within 4 Weeks Prior To Start Of Transplantation|During The Study|Before You Begin The Study:|Before The Transplant:|After Your Transplant|Table 1: Schedule For Health Evaluations After Transplant

Before you begin the study, you will need to have medical examinations, tests, or procedures to find out if you can be in the study. Some of these examinations, tests, and procedures may be part of your regular medical care and may be done even if you do not take part in the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor. After you read this form, you will have a chance to discuss it with your family and friends. If you decide to participate in the study, you will be asked to sign this Informed Consent Form. No study testing or study evaluations will be done before you sign this consent form. The following tests and assessments will be done at the first visit or within 30 days prior to the first visit: - Medical history - Physical examination, including blood pressure, pulse rate, respiratory rate and temperature, and weight
- Blood samples will be taken from a vein in your arm for laboratory blood tests. These tests will evaluate your blood counts, liver and kidney function, blood clotting ability, status of your myeloma, and any other safety evaluations.  
- Blood samples will be taken to test for HIV, Hepatitis B and C, Epstein-Barr Virus
(shingles) and Herpes Simplex Virus. State law requires positive test results for certain communicable diseases, including HIV, hepatitis, sexually transmitted infections, and tuberculosis, to be reported to a local health agency. Some of the tests for this study must be reported when positive. The study doctor can discuss this with you.  
- Heart function tests, including EKG and ejection fraction. - Lung (pulmonary) function tests. - Tests to evaluate your cancer, including a bone marrow aspirate/biopsy. This is where samples of your bone marrow are taken from your hip bone with a needle.  
- Imaging studies if needed depending on your disease - A pregnancy test if you are a woman able to have children. If you are pregnant, you will not be able to take part in this study.  
The initial screening visit may take approximately 3-4 hours, depending on clinic scheduling.

If the examinations, tests, and procedures show that you can be in the study and you choose to take part, you will be enrolled into the study.

If you agree to be in the study, you first sign this Informed Consent form, then you will be asked to participate in the assessments as listed below. Many of these tests and procedures are part of your regular medical care, but they may be done more often for this study.

Before your transplant, your doctor will start the conditioning regimen. The conditioning regimen prepares your body for transplant. It uses chemotherapy to destroy the cancer cells and the cells that make up your immune system.  
| Day -5                               | Day -4   | Day -3   | Day-2   | Day-1   | Day 0   |
|--------------------------------------|----------|----------|---------|---------|---------|
| Fludarabine 30 mg/m2                 | X        | X        | X       | X       |         |
| (in your vein)  Melphalan 70 mg/m2   |          | X        | X       |         |         |
| (in your vein)  Stem Cell Transplant | X        |          |         |         |         |  
Details on the drugs we will give you prior to stem cell transplant are outlined below:

The treatment that are used to prevent GVHD will start after you receive the donor stem cells. These treatments are a combination of drugs that hold back (suppress) your immune system and a standard component of the transplant. You will start the maintenance treatment with Daratumumab between 90-150 days after stem cell transplant and it will continue for 1 year after the first dose as long as counts are acceptable (absolute neutrophil ≥1000/µL; Platelets ≥ 75,000/µL) and in the absence of disease progression. You will receive daratumumab weekly at 16 mg/kg for 8 doses, followed by every 2 weeks for 8 doses, then monthly.  
Health Evaluations after the Transplant (see Table 1)
We will test (evaluate) your health during the study. These tests and how often they are scheduled are standard care for patients receiving transplant. They would be done even if you were not part of this study. You will be watched closely for any signs and symptoms of GVHD.  
  
 OSU-19190 IRB Protocol Number: 2019C0218  
  
  
IRB Approval date: 03/11/2021 Version: 03/03/2021

|                                                                                                                  | Week   | Week   | Week   | Week   | Week   | Week   | Week   | Week   | Week   | Week   | Month   | Month   | Year   | Year   | Year   |
|------------------------------------------------------------------------------------------------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|---------|---------|--------|--------|--------|
| 1                                                                                                                | 2      | 3      | 4      | 5      | 6      | 7      | 8      | 9      | 10     | 3      | 6       | 1       | 1.5    | 2      |        |
| Vital Signs                                                                                                      | x      | x      | x      | x      | x      | x      | x      | x      | x      | x      | x       | x       | x      | x      | x      |
| Score of ability to carry                                                                                        | x      | x      | x      | x      | x      | x      | x      | x      |        |        |         |         |        |        |        |
| out usual activities  Complete blood count                                                                       | x      | x      | x      | x      | x      | x      | x      | x      | x      | x      |         |         |        |        |        |
| Blood test to check the                                                                                          | x      | x      | x      | x      | x      | x      | x      | x      | x      | x      |         |         |        |        |        |
| function of your organs  Blood test to check your                                                                |        | x      | x      | x      | x      | x      |        |        |        |        |         |         |        |        |        |
| ability to fight infections  Blood test to check the  recovery of your  immune function &  Other Related studies |        | x      | x      | x      | x      |        |        |        |        |        |         |         |        |        |        |
| Blood test to monitor  levels of your white blood  cells                                                         | x      | x      | x      | x      | x      | x      | x      | x      | x      | x      | x       | x       | x      |        |        |
| Monitoring for side                                                                                              | x      | x      | x      | x      | x      | x      | x      | x      | x      | x      | x       | x       | x      |        |        |
| effects Acute Graft vs. Host                                                                                     | x      | x      | x      | x      | x      | x      | x      | x      | x      | x      | x       | x       | x      | x      | x      |
| Disease assessment Bone marrow biopsy &  aspirate (response  assessment)                                         |        | x      | x      | x      |        |        |        |        |        |        |         |         |        |        |        |  
This table outlines the different tests and procedures you will undergo while on this study. Each 'X' means that you will have that test or procedure on that particular time.
Clinical trial: NCT04205240
Section: Participant's Rights
Subsections: 12. What Are My Rights If I Take Part In This Study?|Viii. **What If I Decide Not To Give Permission To Use And Give Out My Health** Information?

If you choose to participate in the study, you may discontinue participation at any time without penalty or loss of benefits. By signing this form, you do not give up any personal legal rights you may have as a participant in this study. You will be provided with any new information that develops during the course of the research that may affect your decision whether or not to continue participation in the study. You may refuse to participate in this study without penalty or loss of benefits to which you are otherwise entitled. An Institutional Review Board responsible for human subjects research at The Ohio State University reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of research participants.

Then you will not be able to be in this research study and receive research-related treatment. However, if you are being treated as a patient here, you will still be able to receive care. IX. Is my health information protected after it has been given to others? There is a risk that your information will be given to others without your permission. Any information that is shared may no longer be protected by federal privacy rules.
Clinical trial: NCT04205240
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. What Risks, Side Effects Or Discomforts Can I Expect From Being In The Study?|Infusion-Related Reactions|7. What Benefits Can I Expect From Being In The Study?|11. What Happens If I Am Injured Because I Took Part In This Study?

You will have side effects while on the study. Side effects can range from mild to lifethreatening. The risks and discomforts from this study are similar to what you would have even if you do not join this study. If you do, the effect on you might be better, worse or about the same. Your health care team may give you medicines to help lessen side effects such as feeling sick to your stomach (nausea). In some cases, side effects can be long lasting or may never go away.  
| Fludarabine  Likely (May happen in more than  20% of patients)                                                                                                                                                                                                                                                                                         | Rare, but Serious                                                                                              |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| (May happen in 3% or  fewer patients)                                                                                                                                                                                                                                                                                                                  |                                                                                                                |
|  Anemia (low red blood  cells) which may require  blood transfusions   Cough   Feeling tired or irritable   Infection, especially when  white blood cell count is  low   Low platelet counts, which  may cause bruising or  bleeding   Pain                                                                                                      | Less Likely                                                                                                    |
| (May happen in 20% or fewer  patients, but more than 3%)   Chills   Confusion   Damage to brain, lungs, or  other organs. This may cause  tiredness, changes in thinking  or shortness of breath   Feeling of "pins and needles"  in arms and legs   Nausea, vomiting, loss of  appetite   Sores in mouth which may  cause difficulty swallowing |  Blood in urine   Changes in vision   Kidney damage which  may require dialysis   Liver damage   Seizures |  
| Melphalan  Likely (May happen in more than  20% of patients)                                                            | Rare, but Serious                                              |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| (May happen in 3% or  fewer patients)                                                                                   |                                                                |
|  Anemia (low red blood  cells) which may require  blood transfusions                                                   | Less Likely                                                    |
| (May happen in 20% or fewer  patients, but more than 3%)   Inflammation of blood  vessels   Kidney problems which may |  A new cancer   Allergic reaction which  may cause rash, low |
| Page 9 of 19                                                                                                            | Form date:  05/17/2019                                         |  
|  Diarrhea   Feeling tired   Infection, especially when  white blood cell count is  low   Nausea, vomiting   Sores in mouth which may  cause difficulty swallowing   Swelling of the body   | require dialysis                                                                 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
|  Liver problems which may  cause yellow eyes or skin   Low platelet counts, which  may cause bruising or  bleeding   Scarring of the lungs which  may cause shortness of  breath              | blood pressure,  wheezing, shortness of  breath, swelling of the  face or throat |
|  Heart failure which  may cause shortness of  breath, swelling of  ankles, and tiredness                                                                                                        |                                                                                  |  
| Mycophenolate mofetil (MMF)  Likely (May happen in more than  20% of patients)                                                                                                                                                                                                                                                                                     | Rare, but Serious                                                                                                                                                                                                                                                                                                        |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (May happen in 3% or  fewer patients)                                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                                                                                          |
|  Birth control may not work  as well   Damage to unborn baby if  you become pregnant while  taking this medicine   Difficulty breathing, cough   Headache   High blood pressure   Low white blood cell count  with increased risk of  infection   Nausea, vomiting, diarrhea,  stomach pain   Swelling of the hands, feet,  ankles, or legs   Tremors     | Less Likely                                                                                                                                                                                                                                                                                                              |
| (May happen in 20% or fewer  patients, but more than 3%)   Anemia (low red blood cell  count)   Change in the levels of salts  in the blood   Decreased platelet count,  may cause blood loss into  stool or vomit, increased  bruising   Difficulty falling asleep or  staying asleep   Dizziness   Low blood pressure   Pain in joints or muscles   Rash |  A new cancer   Change in vision   Encephalopathy or  brain dysfunction that  can lead to death   Excessive tiredness   Fast heart beat   Progressive Multifocal  Leukoencephalopathy– This is caused by a  virus that damages the  protective covering in  the brain.   Severe difficulty  breathing   Weakness |
| Cyclophosphamide  Likely (May happen in more than  20% of patients)                                                                                                                                                                                                                                                                                                | Rare, but Serious                                                                                                                                                                                                                                                                                                        |
| (May happen in 3% or  fewer patients)                                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                                                                                                                                                                          |
|  Absence of menstrual cycles  which may decrease the  ability to have children   Blood in urine   Feeling tired   Hair loss, skin changes,  rash, change in nails   Infection, especially when                                                                                                                                                                | Less Likely                                                                                                                                                                                                                                                                                                              |
| (May happen in 20% or fewer  patients, but more than 3%)   Allergic reaction which may  cause rash, low blood  pressure, wheezing, shortness  of breath, swelling of the  face or throat   Decrease in platelets which  may cause bleeding   Decrease in red blood cells,                                                                                       |  A new cancer   Damage to the heart or  heart failure which may  cause shortness of  breath, swelling, cough  or tiredness   Scarring of the lungs  which may cause                                                                                                                                                   |
| Page 10 of 19                                                                                                                                                                                                                                                                                                                                                      | Form date:  05/17/2019                                                                                                                                                                                                                                                                                                   |  
| white blood cell count is  low                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                               |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
|  Nausea, vomiting, diarrhea,  loss of appetite, pain in belly   Sores in mouth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | which may require blood  transfusions                                                         |
|  Loss or absence of sperm  which may lead to an  inability to father children                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | shortness of breath,  fluid around the lungs                                                  |
|  Swelling of the brain  which may cause  dizziness, confusion                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                               |
| Tacrolimus  Likely (May happen in more than  20% of patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Rare, but Serious                                                                             |
| (May happen in 3% or  fewer patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |                                                                                               |
|  Abnormal body movement,  including tremors   Abnormal levels of sugar,  fat, or minerals (like sodium  or potassium) in your blood   Constipation, diarrhea,  nausea, vomiting, reflux,  lack of desire to eat   Difficulty sleeping   Dizziness   Feeling of "pins and  needles" in arms and legs   Headache   High blood pressure which  may cause dizziness, chest  pain   Itching, rash   Kidney damage which may  cause swelling, may require  dialysis   Low red blood cell counts,  which may cause tiredness,  or may require blood  transfusions   Low platelet levels, which  may cause bruising,  bleeding   Low white blood cell  counts, which may lead to  infection   Liver damage   Swelling of the body | Less Likely                                                                                   |
| (May happen in 20% or fewer  patients, but more than 3%)   A new cancer   A tear or a hole in your  bowels which may cause  belly pain and may require  surgery   Allergic reaction which may  cause rash, low blood  pressure, wheezing, shortness  of breath, swelling of the  face or throat   Change in the heart rhythm,  abnormal heartbeat, or heart  stops beating   Damage to brain, which may  cause headache, seizure,  blindness   Damage to lungs, which may  cause shortness of breath,  fluid around lungs   Heart attack or heart failure  which may cause chest pain,  swelling of ankles, and  tiredness                                                                                                        |  Damage to small blood  vessels with resulting  small blood clots and  possible organ damage |  
| Daratumumab  Very Common (affects more than 1 in 10  patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Uncommon                                                                                                                                                                                                                                                                                            |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (affects 1 to 10 in 1,000  patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                                                                                     |
|  Infusion related reaction  (see separate section)   Infection of the upper  respiratory tract infection  such as nose, sinuses throat  or airway   Infection of the lung   Low neutrophils (a type of  white blood cell)   Low platelets   Low red blood cells   Low lymphocytes (a type of  white blood cell)   Numbness/tingling of the  hands, feet or limbs   Headache   Cough   Shortness of breath   Diarrhea   Nausea   Vomiting   Muscle spasms   Fatigue   Fever   Swelling of hands, feet or  limbs | Common                                                                                                                                                                                                                                                                                              |
| (affects 1 to 10 in 100  patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                                                                                     |
|  Flu like symptoms   Sepsis (a life-threatening  condition that arises when  the body's response to an  infection injures its own  tissues and organs)   Irregular heartbeat                                                                                                                                                                                                                                                                                                                                                  |  Shingles (Herpes  zoster)   High blood pressure   Low oxygen in the  body   Swelling of the throat   Inflammation of lung  tissue (pneumonitis)   Fluid in lungs  (pulmonary edema)   Difficulty with blood  testing prior to blood  transfusion (Indirect  Antiglobulin Testing  positive) |

Infusion–related reactions were reported in approximately half of all patients treated with daratumumab. It usually occurs with the first infusion and during or within the first few hours of the start of the infusion. Signs and symptoms of infusion-related reactions may include respiratory symptoms, such as stuffy nose, cough, throat irritation, as well as chills, vomiting and nausea. Less common symptoms are having trouble breathing (wheezing), runny nose, fever, chest discomfort, itching of the skin, and low blood pressure or high blood pressure. Most of the observed infusion-related reactions so far were mild or moderate, and ended by temporarily stopping the infusion and giving medicines to treat the side effect. Severe reactions include narrowing and obstruction of the respiratory airway (bronchospasm), low oxygen, shortness of breath, high blood pressure, swelling in the throat and fluid accumulation in the lungs (pulmonary edema).

Taking part in this study may or may not benefit you. The results of this study may help researchers learn things to better treat future Multiple Myeloma patients.

If you suffer an injury from participating in this study, you should notify the researcher or study doctor immediately, who will determine if you should obtain medical treatment at The Ohio State University Wexner Medical Center. The cost for this treatment will be billed to you or your medical or hospital insurance. The Ohio State University has no funds set aside for the payment of health care expenses for this study.
Clinical trial: NCT04205240
Section: Procedures
Subsections: 3. What Will Happen If I Take Part In This Study?

If you are eligible to take part in the study, agree to participate, and sign this Informed Consent Form, you will have the screening tests and procedures listed below. No study procedures will be done until after you sign this form. We will check your health before you start treatment, while you receive treatment, and for 2 years after transplant. Female subjects: We do not know if the study drugs will affect mother's milk or an unborn child. Therefore, breast-feeding and pregnant women are not allowed to take part in the study. Due to unknown risks and potential harm to the unborn child/ infant, you should not become pregnant or nurse a baby while on this study. You must have a negative pregnancy test prior to enrolling in the study.  
Unless you cannot have children because of surgery or other medical reasons (you had an effective tubal ligation: you had the ovaries or the uterus removed; or you are postmenopausal), you must use two effective methods of birth control or agree to practice true abstinence, from the time of signing the informed consent form, for the entire study drug treatment period (including interruptions in treatment), and for 90 days after completing study drug treatment. Periodic abstinence, meaning that you abstain from sex only on certain days of the months, and withdrawal are not acceptable methods of contraception. It is strongly recommended that at least one of these two methods be highly effective (see examples below). Highly effective methods: Intra-uterine devices (IUD) Hormonal (birth control pills/oral contraceptives, injectable contraceptives, contraceptive patches Other effective methods: Barrier Latex or non-latex condom with or without a spermicidal agent Diaphragm with spermicide; Cervical cap with a spermicide; Sponge with a spermicide. If one of the highly effective methods cannot be used, using two effective methods at the same time are recommended. Male subjects: We do not know if using the study drugs will affect sperm. Therefore, due to potential risk, you should not get your partner pregnant during the study drug treatment period (including interruptions in treatment). Even if you are surgically sterilized (i.e. have had a vasectomy) you must agree to use an appropriate method of barrier contraception (latex or non-latex condom with or without a spermicidal agent), or agree to practice true abstinence, during the entire study drug treatment period, and for 90 days after completing study drug treatment. Periodic abstinence, meaning that you abstain from sex only on certain days of the months, and withdrawal are not acceptable methods of contraception.  
Page 4 of 19 Form date:
05/17/2019 Highly effective methods: Vasectomy Other effective methods: Barrier Latex or non-latex condom with or without a spermicidal agent Diaphragm with spermicide; Cervical cap If one of the highly effective methods cannot be used, using two effective methods at the same.
Clinical trial: NCT04205240
Section: Purpose of Research
Subsections: 1. **Why Is This Study Being Done?**

You have been invited to participate in this research study, because you have relapsed multiple myeloma that is resistant to chemotherapy, with or without prior autologous HSCT, and with a partial response or better prior to allo-transplantation. Your study doctor will explain the clinical study to you. This research study includes only patients who choose to take part. Your participation is entirely voluntary. To allow you to make an informed decision as to whether or not you want to take part in this research study, this document describes the purpose of the study, your rights and obligations, the procedures needed by the study, and the possible benefits and risks of participating in the study. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You may also discuss it with your health care team. If you have any questions, you may ask your study doctor for more explanation. In this consent form, "you" refers to the patient. A blood stem cell transplant is a standard treatment for blood cancers such as acute and chronic leukemias, lymphoma and myelodysplastic disorders. It replaces the abnormal (or diseased) blood cells with healthy cells from a donor. It requires a close tissue match between you and the donor. Your donor could be a family member, or it could be an unrelated person. The chemotherapy you get to destroy the abnormal cells and prepare your body for transplant is called the conditioning regimen. When lower doses of chemotherapy than usual are given, it's called a reduced-intensity conditioning regimen. A common problem that may occur after a blood stem cell transplant is a condition known as Graft-Versus-Host Disease (GVHD). The "graft" is the donor blood cells that you will get during your transplant. The "host" is the person (in this case, you) receiving the cells. GVHD
is when the donor graft attacks and damages some of your (the transplant recipient's) tissues.  
GVHD can cause skin rash, stomach (intestinal) problems such as nausea, vomiting, or diarrhea It may also damage your liver and cause hepatitis or jaundice (yellowing of the skin). GVHD may also increase your risk of infection.
Clinical trial: NCT04205240
Section: Withdrawal from Study
Subsections: 5. **Can I Stop Being In The Study?**|Vii. **May I Withdraw Or Revoke (Cancel) My Permission?**

You may leave the study at any time. If you decide to stop participating in the study, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled. Your decision will not affect your future relationship with The Ohio State University.

Yes. Your authorization will be good for the time period indicated above unless you change your mind and revoke it in writing. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the researchers. If you withdraw your permission, you will not be able to stay in this study. When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others.