Clinical trial: NCT03398200
Section: Alternatives
Subsections: Alternatives

You can choose not to be in the study. Instead of being in this study, you can receive the preparative treatment plan without the HBO therapy, which is standard procedure for the Auto-HSPC transplant. The care you receive from your doctor will not be affected in any way, whether or not you decide to be in the study.
Clinical trial: NCT03398200
Section: Confidentiality
Subsections: University Of Rochester Statement On Access To Information About **Your Study Participation** In Your Electronic Health Record|Confidentiality Of Records And **Authorization To Use And Disclose Information For Research** Purposes

The following information about your study participation will be included in your electronic health record: - Documenting you are in this study - A copy of your signed consent form - Results of all routine testing such as: vital signs, height and weight, ECGs, routine blood tests, CT or MRI scan results, and biopsy results.  
The study team may be notified if you receive other health care services at URMC or its Affiliates (e.g., visit to the emergency room). In addition, the following individuals may know you participated in research and may see results of testing conducted for this study:
- Staff at the University of Rochester Medical Center and its Affiliates (e.g., Strong Memorial Hospital, Highland Hospital, URMC primary care, specialist physician offices) who have a reason to access your electronic health record.  
- Health care providers who are involved in your care at a facility that is not part of the University of Rochester Medical Center and its Affiliates and who have reason to access your electronic health record.  
- Individuals who request a copy of information from your health record for activities such as
Page 8 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8)

The University of Rochester makes every effort to keep the information collected from you private. In order to do so, we will limit access to research databases to only the approved research staff working on the study. Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the study sponsor. If you have never received a copy of the University of Rochester Medical Center (URMC) and Affiliates Notice of Privacy Practices, please ask the investigator for one.  
What information may be used and given to others?  
The study doctor will get your personal and medical information. For example:
- Research records - Records about phone calls made as part of this research - Records about your study visits - Past and present medical records related to the study - Results of medical tests Who may use and give out information about you?  
- The study doctor and the study staff - URMC and Affiliates  
Your information may be given to:
- The Department of Health and Human Services - The University of Rochester - The U.S. Food and Drug Administration (FDA) may also need to inspect study records at some point during the study or even after it has been completed. In the event that this should occur, every effort will be made to keep identifying information about you private.
Why will this information be used and/or given to others?  
- To do the research - To study the results - To see if the research was done right If the results of this study are made public, information that identifies you will not be used. What if I decide not to give permission to use and give out my health information?  
- Then you will not be able to be in this research study.  
Page 9 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8) May I review or copy my information?  
- Yes, but only after the research is over.  
How long will this permission be valid?  
- This permission will last indefinitely.  
May I cancel my permission to use and disclose information?  
- Yes, you may cancel your permission to use and disclose your health information at any time.  
You do this by sending written notice to the study doctor. Upon receiving the written notice, the study team will no longer use or disclose your health information and you will not be able to stay in this study. Information that has already been gathered may need to be used and given to others for the validity of the study. .  
May I withdraw from the study?  
- Yes. If you withdraw your permission to be in the study, 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.  
Is my health information protected after it has been given to others?  
- No, there is a risk that your information will be given to others without your permission.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S.  
Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time.
Clinical trial: NCT03398200
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks|Risks Related To Blood Draws:|Radiation Risks|Pregnancy Risks|Possibility Of Unknown Risks

The hyperbaric oxygen chamber therapy may cause side effects or other problems. The researchers will be checking your medical information during the study to watch for side effects. However, you should tell the research team about anything that is bothering you or any changes in your health since the last visit. The researchers may be able to take steps to reduce side effects. You may experience none, some, or all of the side effects listed below. Risks Related to the Hyperbaric Oxygen Chamber Therapy: When you are placed into the hyperbaric oxygen chamber, you may not feel any changes. However, during certain parts of the treatment, you may experience a sensation of fullness in the ears, similar to the feeling experienced on an airplane. This is a result of the eardrum responding to pressures changes. Prior to treatment, you will be taught a few easy methods to "clear" your ears to avoid discomfort.  
The most common side-effects of the HBO chamber therapy include:
- Claustrophobia (having fear or anxiety of enclosed spaces) - Ear popping. - Temporary myopia, or nearsightedness (a vision condition in which close objects are seen clearly, but objects farther away appear blurred). If you experience temporary myopia, it might take several weeks to get better.
Rare, but serious risks of the HBO chamber therapy include:
- Lung irritation by the oxygen (This can cause a dry cough, chest tightness, and a decline in lung function. These symptoms may not go away for weeks.  
- Seizures, or convulsions (Seizures can be reversed in the chamber by reducing the pressure of oxygen)

Page 5 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8)
You will need to have samples of blood taken during the study for laboratory testing. You may experience temporary discomfort from these periodic blood draws. These needle sticks may cause local pain, bruising and swelling, lightheadedness, dizziness and rarely, fainting and/or a local infection.  
Risks Related to the Auto-HSPC Transplant and Preparative Treatment Plan:
You have already agreed to receive an Auto-HSPC transplant. The HSPC transplant is a standard clinical procedure for multiple myeloma. All chemotherapy treatments used to prepare you for your transplant are commonly used in Auto-HSPC transplantations as standard of care. A separate consent will be provided to you to describe risks involved for the transplant, including risks involved for the treatment plan used to prepare you for it.

The use of the MUGA scan or CT/PET scans might be part of your routine care and you could receive it whether you were in this study or not. There is no additional risk from radiation exposure because you are participating in this study. If you have any concerns about radiation exposure, please ask the study doctor.

The procedures used for your Auto-HSPC transplant might hurt an unborn child or a child who is breastfeeding. If you are a female you cannot be in this study if you are pregnant or nursing a baby. You cannot be in this study if you are trying to get pregnant, or if you are a male and are planning on fathering a child. If you are female, you will have a pregnancy test before the study starts. During the study you must use an approved method of birth control. These include:
- Abstinence (refraining from all acts of vaginal sex) - Hormonal methods (oral contraceptives, implants or injections) - Barrier methods (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom)
- Intrauterine devices (e.g., Copper T)
- Female tubal sterilization - Male vasectomy sterilization The study doctor must approve the form of birth control. You must talk to your study doctor before changing any birth control methods you have already agreed to use.  
There may be pregnancy risks that are not known yet. For this reason, you must tell the researcher right away if you get pregnant during the study. If you are male and your female partner becomes pregnant, you must also tell the researcher right away. If a pregnancy occurs while you (or your partner) are participating in this study, the researcher may request information related to the pregnancy including pregnancy details, details of the birth, the presence or absence of any birth defects, and any maternal or newborn complications.

Because this approach has not been tried before, there may be other side effects or risks that are not yet known. There is a risk that the HBO might lower the efficacy of the transplant treatment.  
Page 6 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8)
Clinical trial: NCT03398200
Section: Procedures
Subsections: Procedures

Most of the procedures performed in this study are part of your regular cancer care (typically called
"standard of care"). These procedures would be part of your cancer care whether or not you participate in the study. The standard of care procedures will all be explained to you by your study doctor. You may be asked to sign a separate consent form for the Auto-HSPC transplant. If you are eligible and agree to participate in this study, the following standard of care procedures and procedures for research will take place:
Prior to Transplant:
You will be asked to sign this informed consent document. If you decide to participate in this study, you will be assigned by chance (like flipping a coin) to one of two groups. Group 1 will receive the standard Auto-HSPC transplant and Group 2 will receive the HBO in addition to their standard Auto-HSPC. There is an equal chance that you will be assigned to either group.  
You will receive standard treatment to prepare you for the Auto-HSPC transplant. This will include the following routine procedures and tests:
- Obtaining medical history and medications you are currently taking - Physical exam with vital signs (this includes blood pressure, temperature, breathing, height, and weight)
- Routine clinical laboratory tests including blood (about 5 teaspoons) and urine tests. - MUGA or Echo testing (used to assess heart function) - Pulmonary (or lung) function tests - Urine pregnancy test (if you are a female of childbearing potential). If you are pregnant, or currently breast feeding, you cannot participate in this study.
In addition, you will receive chemotherapy (melphalan) as part of your standard of care prior to the AutoHSPC transplant. Additional information about this process and your standard of care treatment will be provided by the study doctor. You may be asked to sign a separate consent form.  
- For HBO Subjects Only:
You will visit the Strong Wound Healing Center for an HBO risk assessment visit prior to receiving your HBO therapy.  
Day of Transplant:
On the day of your Auto-HSPC transplant, your doctor will perform a routine transplant evaluation. You will also have blood samples (approximately 1.5 teaspoons) taken for routine laboratory testing. Page 3 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8)
- For HBO Subjects Only:
After your routine evaluation and laboratory testing is complete, an additional blood sample (approximately 1 teaspoon) will be collected for research purposes. This sample will be used to test for the hormone, EPO, and for proteins that control inflammation (called cytokines).  
You will then go to the Strong Wound Healing Center for the experimental HBO therapy. You are responsible for transporting yourself to and from this location and will be given instructions on where to go before and after HBO therapy. If you are prescribed a medication to relax you (sedative) related to HBO therapy, you will need to arrange for transportation to and from the Strong Wound Healing Center. You will lie in a single hyperbaric chamber where 100% oxygen will be released, pressurized at 2
½ times the normal atmospheric pressure. The following will occur during this time:
- For about the first 10-15 minutes in the chamber, the air pressure will be increased, and the 100% oxygen will fill the chamber.  
- During the 2 hours, there will be compression and decompression phases for 10 minutes each in which you will be breathing compressed environmental air (21% oxygen).  
- After you breathe the 100% oxygen at increased pressure for 90 minutes, the chamber will need to decompress. This takes about 10-15 minutes.  
After you receive the HBO therapy, you will be admitted to the hospital. It is recommended that you shower at the hospital using chlorhexidine (CHG) soap (which will be provided to you), but it is not required. Four additional blood samples (approximately 1 teaspoon each), for research will then be collected at the following time points to test for cytokines and EPO:
- 6 hours after the start of HBO therapy (prior to the Auto-HSPC transplant) - 8, 24, and 48 hours after the start of HBO therapy.  
Following the 6 hour blood draw for research, you will receive your scheduled HSPC transplant. Within 24 hours of your HBO therapy, you will have a physical exam and your vital signs will be measured to check for any side effects that may have been caused by the HBO therapy.
Clinical trial: NCT03398200
Section: Purpose of Research
Subsections: Purpose

By doing this study, researchers hope to learn the following:
- The effects of HBO therapy on the engraftment process and patient recovery following transplant. - The effects of HBO therapy on hospital stay, blood and platelet transfusion needs, use of growth factors, and incidence and severity of mucositis.  
- The effects of HBO on recovery of peripheral blood lymphocytes, including the natural killer Page 2 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8)
(NK) cell subset.  
- The effects of HBO on multiple myeloma disease control.
Clinical trial: NCT03398200
Section: Withdrawal from Study
Subsections: Subject Rights And Withdrawal From The Study You May Stop Being In The Study At Any Time Within The Study Duration (1 Year From The Date Of Transplant).

Your decision to stop participation will not prevent you from getting treatment or services at Strong Wound Healing Center, Strong Memorial Hospital or Wilmot Cancer Institute. If you decide to stop the HBO therapy session while in the HBO chamber, the researchers will first need to decrease the pressure Page 10 of 15 CTO Version Date: 04Nov2021 Protocol Version Date: 26Aug2021: (Amend. \#8)
in the chamber until it is returned to a normal level so you are not harmed by stopping the therapy suddenly. You might be asked to come back for a final study visit. You have the right to cancel your permission for researchers to use your health information. If you want to cancel your permission, please write to Dr. Omar Aljitawi. The mailing address is Dr. Omar Aljitawi, University of Rochester Medical Center, 601 Elmwood Avenue, Box 704, Rochester, NY 14642. If you cancel permission to use your health information, you will be withdrawn from the study. The researchers will stop collecting any additional information about you unless they need information about a side effect of the study device. They may use and share information that was gathered before they received your cancellation. This study might be stopped, without your consent, by the investigator or by the FDA. Your participation also might be stopped by the investigator if it is in your best interest or if you do not follow the study requirements.  
Neither the investigator, nor the University of Rochester Medical Center will be obligated to provide you with the study treatment if the study is stopped early. Your physician will decide about future treatment, if it is needed.