Clinical trial: NCT02073097
Section: Confidentiality
Subsections: 9.  Privacy And Confidentiality|Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study

Your information will be kept in a coded form and not attached to your name. We will store the code in a secure area and allow only the study team (the researchers, research nurse and other study staff) to have access to this code. We will keep this code in order to maintain a link between your name and the information about you created and collected during this study. The coded information, without your name attached, may be shared with others outside the research.

If you volunteer to participate in this research, your protected health information (PHI)
that identifies you will be used or disclosed to Dr. Brian Hill, Dr. Kirsten Boughan, and the research staff at Cleveland Clinic for the purposes of this research and to Case Western Reserve University for administration.  
The PHI that we may use or disclose (release) for this research may include your name, address, phone number, date of birth, Social Security number, information from your medical record, lab tests, or certain information relating to your health or condition.  
Some of the tests and procedures done solely for this research study may also be placed in your medical record so other doctors know you are in this study.  Upon completion of the study, you may have access to the research information that is contained in your medical record.  
In addition to the investigators and research staff listed above, your PHI may be looked at by other groups involved with the study such as the Cleveland Clinic Institutional Review Board, and the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee.  Your PHI may also be used by and/or disclosed (released) to:
. . . .  
Case3413, Main Study Consent  
The study's investigational product supplier, Amgen, its licensees and collaborators, and all the clinical research organization that help manage the study; Federal agencies, such as the Food and Drug Administration, the Department of Health and Human Services, and the National Cancer Institute (NCI);
Other Institutional Review Boards; Data Safety and Monitoring Boards; An independent committee of physicians and experts that will review safety information from this study periodically
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Hospital accrediting agencies Individuals or businesses outside the hospital that provide services; for example, insurance companies, legal offices and data storage companies Regulatory agencies from other countries; quality assurance and/or quality cntrol auditors
Once your personal health information is released it may be re-disclosed and no longer protected by privacy laws.  
Your research information may be used and disclosed indefinitely but you may stop these uses and disclosures at any time by writing to Brian Hill, MD, PhD,  9500 Euclid Avenue, CA6, Cleveland, OH 44195, (216) 445-9451, or Kirsten Boughan, DO, Division of Hematology/Oncology, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, (216) 844-3951. If you revoke this Authorization, your participation in the research will stop, but any information ly recorded about you cannot be removed from the records and will continue to be used as a part of this research and by the individuals and organizations as described in this Authorization. Also, information already disclosed outside the Cleveland Clinic cannot be retrieved. This will not affect your rights to treatment or benefits outside the research study.  
The Cleveland Clinic and University Hospitals will not use your information collected in this study for another research purpose without your written permission unless the Cleveland Clinic Institutional Review Board (IRB) or University Hospitals IRB assures your privacy and confidentiality is protected.  The IRB is a committee whose job it is to protect the safety and welfare of research subjects.  
By signing this informed consent form, you are authorizing such access to your research and medical record information.  If you choose not to sign this consent form, you will not be able to participate in this research study.  This Authorization does not have an expiration date.
Clinical trial: NCT02073097
Section: Duration of Study Involvement
Subsections: Treatment Period|Cycle 1, Day 8 Optional At Physician'S Choice|Cycles 2-6, Day 8 - Optional At Physician'S Choice|Cycle 3, Day 15-21|Cycle 6, Day 21 Off Treatment Visit (To Be Conducted Within 50 Days Of Day 1 Of Last Treatment)

Treatment cycles are 21 days long.  
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Physical Examination
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Weight
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Vital signs including: blood pressure, pulse, respiratory rate and temperature. We will ask you about the medications you are taking including prescription medications, over-the-counter (OTC) medications and natural/herbal
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supplements.  
ECOG Performance Status We will ask you about any side effects you may be having.  
Baseline Symptoms Assessment Blood samples will be collected in order to see how well your organs are functioning.  
Carfilzomib administration intravenously (into the vein)
You will start to take a medication called Acyclovir.  This is used to treat and prevent viral infections from the virus that causes chicken pox and shingles.  
Some patients develop shingles while receiving chemotherapy as a result of reactivation of dormant (temporarily inactive) virus during treatment.  
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Vital signs including: blood pressure, pulse, respiratory rate and temperature.  
We will ask you about any side effects you may be having.  
Carfilzomib administration Rituximab administration intravenously (into the vein)
Case3413, Main Study Consent  
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Vital signs including: blood pressure, pulse, respiratory rate, and temperature. CHOP administration.  Cyclophosphamide, Doxorubicin, and Vincristine are administered intravenously (into the vein) and Prednisone is administered
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orally (by mouth)  
- Pegfilgrastim administration subcutaneously (under the skin) or ONPRO™
wearable device

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Blood samples may be collected in order to see how well your organs are functioning:
o o  
Complete Blood Count (CBC) with differential and platelets Serum Chemistries: albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose,  potassium, total protein, SGOT [AST], SGPT [ALT], sodium, lactate dehydrogenase (LDH) level, uric acid, phosphorous.  
Calculated creatinine clearance will be determined using Cockcroft-
Gault formula if creatinine and/or BUN are abnormal.
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Physical Examination
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Weight
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Vital signs including: blood pressure, pulse, respiratory rate and temperature.  
Carfilzomib administration Rituximab administration
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Vital signs including: blood pressure, pulse, respiratory rate and temperature. We will ask you about the medications you are taking including prescription
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medications, over-the-counter (OTC) medications and natural/herbal supplements.  
ECOG Performance Status
. .  
We will ask you about any side effects you may be having.  
Blood samples will be collected in order to see how well your organs are
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functioning.  
Carfilzomib Administration
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Case3413, Main Study Consent  
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Vital signs including: blood pressure, pulse, respiratory rate, and temperature.  
CHOP administration.  
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Pegfilgrastim administration

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Blood samples may be collected in order to see how well your organs are functioning. A test called Complete Blood Count will be done.

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CT scan of neck, chest, abdomen and pelvis with oral and IV contrast (neck may be omitted at discretion of treating physician).  
PET/CT scan (optional)
Your physician will assess how are your responding to the study drug
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Echocardiogram Bone Marrow Aspirate and Biopsy (may be omitted if screening bone marrow biopsy was negative for involvement for lymphoma) CT scan of neck, chest, abdomen and pelvis with oral and IV contrast (neck may be omitted at discretion of treating physician).  
PET/CT to be obtained between 4-8 weeks after cycle 6, day 1. Unless your physician decides to defer these procedures until you complete other types of therapy such as radiation.  
Your physician will assess how are your responding to the study drug Physical Examination Weight Vital signs including: blood pressure, pulse, respiratory rate and temperature. We will ask about the medications you are taking including prescription medications, over-the-counter (OTC) medications and natural/herbal supplements.  
ECOG Performance Status We will ask you about any side effects you may be having.  
Blood samples will be collected in order to see how well your organs are functioning.  
EKG
Case3413, Main Study Consent
Clinical trial: NCT02073097
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 4. Risks|Carfilzomib Risks & Side Effects|Vincristine Risks & Side Effects|Cyclophosphamide, Doxorubicin, Prednisone Risks & Side Effects|Unknown Risks

You may have all, some, or none of the known side effects described in the following sections.  There is also a risk that other rare or unknown side effects may occur.  Your doctors and nurses will check you closely for side effects, and may give you medicines or other treatments to stop or reduce some of these effects.  Some side effects may go away soon after the study medication is stopped, but in some cases, side effects may be serious, long lasting, and/or permanent.  There is even a chance that a side effect may cause death.  
| Very common side effects (may affect more than 1 in 10 people) include:   |                                    |                                   |               |
|---------------------------------------------------------------------------|------------------------------------|-----------------------------------|---------------|
| Low red blood cell count (anemia)                                         | Infusion reactions                 |                                   |               |
| .                                                                         | .                                  |                                   |               |
| which may cause tiredness and                                             | Respiratory tract infection        |                                   |               |
| fatigue                                                                   | Lung infection (pneumonia)         |                                   |               |
| .                                                                         |                                    |                                   |               |
| .                                                                         | Low platelets, which may cause     | Runny nose or nasal congestion    |               |
| .                                                                         |                                    |                                   |               |
| easy bruising or bleeding                                                 | Decreased appetite                 |                                   |               |
| .                                                                         |                                    |                                   |               |
| Low white blood cell count, which                                         |                                    |                                   |               |
| .                                                                         | Back pain                          |                                   |               |
| .                                                                         |                                    |                                   |               |
| may decrease your ability to fight                                        | .                                  | Joint pain                        |               |
| infection                                                                 | .                                  | Pain in limbs, hands, or feet     |               |
| .                                                                         | Shortness of breath                | .                                 | Muscle spasms |
| Cough; Cough with phlegm                                                  |                                    |                                   |               |
| .                                                                         | .                                  | Headache                          |               |
| .                                                                         | Diarrhea                           | Dizziness                         |               |
| .                                                                         |                                    |                                   |               |
| Nausea                                                                    |                                    |                                   |               |
| .                                                                         | Numbness, tingling, or decreased   |                                   |               |
| .                                                                         |                                    |                                   |               |
| Constipation                                                              |                                    |                                   |               |
| .                                                                         | sensation in hands and/or feet     |                                   |               |
| Vomiting                                                                  |                                    |                                   |               |
| .                                                                         | .                                  | Insomnia (difficulty sleeping)    |               |
| Stomach pain                                                              |                                    |                                   |               |
| -                                                                         | .                                  | Changes to blood tests (decreased |               |
| .                                                                         | Tiredness (fatigue)                | blood levels of potassium,        |               |
| .                                                                         | Fever                              | increased blood levels of sugar   |               |
| .                                                                         | Swelling of the hands, feet, or    | and/or creatinine                 |               |
| ankles                                                                    | High blood pressure (hypertension) |                                   |               |
| General weakness                                                          |                                    |                                   |               |

| Common side effects (may affect up to 1 in 10 people) include:   |                                     |
|------------------------------------------------------------------|-------------------------------------|
| Low white blood cell count, which                                | Inflammation of the nose and throat |
| may be associated with fever                                     | Flu-like symptoms (influenza)       |
| .                                                                |                                     |  
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Feeling too hot Pain, swelling, irritation or discomfort where you received the injection into your vein Liver problems including an increase in your liver enzyme in the blood
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Sore throat
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Bronchitis
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Urinary tract infection
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Anxiety Kidney problems including decreased ability to make urine, increased creatinine in the blood, and kidney failure needing dialysis Rash
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Itchy skin
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| Redness of the skin                    |
|----------------------------------------|
| Increased sweating                     |
| Changes to blood tests (decreased      |
| blood levels of sodium, magnesium,     |
| protein, calcium, or phosphate,        |
| increased blood levels of calcium,     |
| uric acid, potassium, bilirubin, or c- |
| reactive protein                       |
| Low blood pressure (hypotension)       |
| Blood clots in the veins               |  
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Uncommon side effects (may affect up to 1 in 100 people) include:
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tiredness Lung problems Case3413, Main Study Consent Heart attack Reduced blood flow to the heart Abnormal amount of fluid between the heart and the lining of the heart Swelling and irritation of the lining around the heart Heart muscle disease with may cause shortness of breath and  
| Extremely high blood pressure   |                            |
|---------------------------------|----------------------------|
| .                               | Bleeding in the brain      |
| .                               | Allergy to Carfilzomib     |
| .                               | Tumor lysis syndrome (TLS) |
| o                               | Tumor lysis syndrome is    |
| caused by rapid killing of      |                            |
| tumor cells during treatment.   |                            |
| When the tumor cells die,       |                            |
| they release their contents     |                            |  
Heart failure, and heart problems including rapid, strong, or irregular heartbeat Blood clot in the lungs Fluid in the lungs Nose bleed Change in voice or hoarseness Pain in throat Serious infection in the blood
(sepsis)
Viral infection Dehydration Bone and muscle pain Chest pain Muscle weakness Aching muscles Wheezing Pulmonary hypertension Blurred vision Cataract Indigestion Toothache Pain Chills Stroke
.  
| into the bloodstream.  If cell                                 |                                     |                               |
|----------------------------------------------------------------|-------------------------------------|-------------------------------|
| .                                                              | Bleeding in the lungs               |                               |
| Perforation in the stomach, small                              | killing is very rapid, this can     |                               |
| .                                                              | intestine, or large bowel           | affect blood chemistries and  |
| .                                                              | Bleeding in the stomach and bowels  | the kidneys.  In severe       |
| cases, this can lead to                                        |                                     |                               |
| .                                                              | Multi-organ failure                 | shutdown of kidney function   |
| .                                                              | Liver failure                       | requiring dialysis.           |
| .                                                              | Itchy skin, yellow skin, very dark  |                               |
| urine, and very pale stools which                              |                                     |                               |
| may be caused by a blockage in the                             |                                     |                               |
| flow of bile from the liver                                    |                                     |                               |
| (cholestasis)                                                  |                                     |                               |
| Rare side effects (may affect up to 1 in 1000 people) include: |                                     |                               |
| Thrombotic Thrombocytopenic                                    | Posterior reversible encephalopathy |                               |
| Purpura/Hemolytic Uremic                                       | syndrome (PRES)                     |                               |
| Syndrome (TTP/HUS) - signs of                                  | Formerly termed reversible          |                               |
| o                                                              |                                     |                               |
| this blood condition may include                               | posterior                           |                               |
| bleeding, bruising, weakness,                                  | leukoencephalopathy                 |                               |
| confusion, fever, nausea, vomiting,                            | syndrome (RPLS).  PRES is           |                               |
| diarrhea, and acute kidney failure.                            | a rare, neurological disorder       |                               |
| .                                                              | Thrombotic microangiopathy          | which can present with        |
| seizure, headache, lethargy,                                   |                                     |                               |
| .                                                              | Venous thromboembolism              | confusion, blindness, altered |
| .                                                              | Swelling of the throat              | consciousness, and other      |
| .                                                              | Infection of the back of the eye    |                               |
| (Cytomegalovirus)                                              | visual and neurological             |                               |
| disturbances, along with                                       |                                     |                               |
| .                                                              | Progressive Multifocal              | hypertension.  The diagnosis  |
| Leukoencephalopathy -  a rare                                  | is confirmed by                     |                               |
| infection of the brain caused by the                           | neuroradiological imaging.  If      |                               |
| JC (John Cunningham) virus.                                    | diagnosed early and treated,        |                               |
| Symptoms include general                                       | the symptoms of PRES may            |                               |
| weakness, issues with balance,                                 | be reversed.  Cases of              |                               |
| difficulty speaking and sensory loss.                          | PRES have been reported in          |                               |
| .                                                              | Reinfection of the liver with the   | patients receiving            |
| hepatitis B virus                                              | Carfilzomib.  Discontinue           |                               |
| .                                                              | Pancreatitis                        | Carfilzomib if PRES is        |
| suspected.  The safety of                                      |                                     |                               |
| reinitiating Carfilzomib                                       |                                     |                               |
| therapy in patients previously                                 |                                     |                               |
| experiencing PRES is not                                       |                                     |                               |
| known                                                          |                                     |                               |  
Case3413, Main Study Consent Myelodysplastic syndromes (MDS)/Acute Myeloid Leukemia (AML) - Myelodysplastic syndromes refer to a disorder that develops when the cells in the bone marrow (the soft inner part of the bones where new blood cells are made) do not work properly and have problem making new blood cells.  A person with MDS may experience no symptoms or may experience fatigue, infection, easy bruising or bleeding.  MDS can turn into a cancer of bone marrow cells called acute myeloid leukemia (AML).  
Recent studies have shown that patients from the Asia-Pacific region (China, Japan, Taiwan, Singapore, Republic of Korea, and Thailand)are at an increased risk of cardiovascular events from Carfilzomib. Patients who are of Asian-Pacific ethnicity or ancestry should not be enrolled in this study to ensure patient safety. Please let your study doctor know if you have any concerns.

Side effects that have been seen in patients who have received treatment with vincristine include the following:  
| Alopecia (hair loss)                  | Loss of fertility (males)           |                             |                                   |
|---------------------------------------|-------------------------------------|-----------------------------|-----------------------------------|
| Anemia (decrease in the number of     | .                                   | Loss of reflexes            |                                   |
| .                                     | red blood cells)                    | Pain due to nerve damage    |                                   |
| .                                     | Blindness and deafness due to       | .                           | Muscle wasting                    |
| nerve damage                          | Loss of ability to control bladder  |                             |                                   |
| Blockage of the intestines            | leading to increased or decreased   |                             |                                   |
| .                                     |                                     |                             |                                   |
| .                                     | Blockage of the vein leading from   | frequency of urination      |                                   |
| your liver to your heart (can lead to | Leukopenia (decrease in the         |                             |                                   |
| liver or kidney damage)               | nmber of white blood                |                             |                                   |
| .                                     | Bone pain                           | clls)frequency of urination |                                   |
| Changes in the way you walk (e.g.,    | Nausea                              |                             |                                   |
| .                                     | with a flat foot)                   | Rash                        |                                   |
| .                                     |                                     |                             |                                   |
| .                                     | Constipation                        | .                           | Seizures                          |
| .                                     | Decreased blood platelets which     | .                           | Second cancer in addition to your |
| can affect blood clotting             | lymphoma (e.g., leukemia)           |                             |                                   |
| .                                     | Damage to the intestines that could | Sensory loss                |                                   |
| .                                     |                                     |                             |                                   |
| make it hard to digest food           | Shortness of breath                 |                             |                                   |
| .                                     |                                     |                             |                                   |
| -                                     | Diarrhea                            | Sores in the mouth          |                                   |
| .                                     |                                     |                             |                                   |
| .                                     | Difficulty breathing                | Stomach cramps              |                                   |
| Difficulty walking                    | Uncontrollable shaking              |                             |                                   |
| .                                     |                                     |                             |                                   |
| Feeling of "pins and needles" in skin | Women may stop having periods       |                             |                                   |
| Case3413, Main Study Consent          |                                     |                             |                                   |  
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•  
| High or low blood pressure             | .   |
|----------------------------------------|-----|
| Inability to move certain parts of the |     |
| body                                   | .   |
| Jaw pain                               | .   |  
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Water retention and decreased blood sodium Loss of reflexes Kidney damage that can lead to kidney failure Rare cases of severe allergic reaction to vincristine have been reported.

Cyclophosphamide, doxorubicin, and prednisone are drugs that have been approved by the FDA.  The following side effects have been commonly seen in patients with cancer  
| who have received treatment with these drugs:                                     |                                     |                                 |                                  |
|-----------------------------------------------------------------------------------|-------------------------------------|---------------------------------|----------------------------------|
| Allergic reaction*                                                                | Nosebleeds                          |                                 |                                  |
| .                                                                                 | .                                   |                                 |                                  |
| Alopecia (hair loss)                                                              | Loss of fertility (males)           |                                 |                                  |
| .                                                                                 | .                                   |                                 |                                  |
| Bleeding gums                                                                     | Low platelets that can lead to      |                                 |                                  |
| .                                                                                 | .                                   |                                 |                                  |
| .                                                                                 | Changes in nail                     | bruising or bleeding            |                                  |
| .                                                                                 | Changes in the way your heart       | .                               | Low red blood cells              |
| works possibly causing irreversible                                               | Pain at the injection site or along |                                 |                                  |
| .                                                                                 |                                     |                                 |                                  |
| heart failure                                                                     | the vein                            |                                 |                                  |
| .                                                                                 | Changes in skin color               | Nausea                          |                                  |
| .                                                                                 |                                     |                                 |                                  |
| .                                                                                 | Changes to the lungs                | .                               | Pain when urinating              |
| .                                                                                 | Chills                              | .                               | Puffy face                       |
| .                                                                                 | Constipation                        | .                               | Rash                             |
| .                                                                                 | Cough                               | .                               | Sore mouth and ulcers            |
| .                                                                                 | Diarrhea                            | .                               | Sore throat                      |
| Difficulty sleeping                                                               | Stomach pain                        |                                 |                                  |
| .                                                                                 | .                                   |                                 |                                  |
| Excessive thirst                                                                  |                                     |                                 |                                  |
| .                                                                                 | .                                   | Swelling due to fluid retention |                                  |
| Fever                                                                             | Taste changes                       |                                 |                                  |
| .                                                                                 | .                                   |                                 |                                  |
| .                                                                                 | Frequent urination                  | .                               | Tiredness                        |
| .                                                                                 | Headaches                           | .                               | Urine discoloration              |
| .                                                                                 | Itchiness                           | .                               | Vomiting                         |
| .                                                                                 | Jaw pain                            | .                               | Weight gain (increased appetite) |
| .                                                                                 | Muscle aching                       | .                               | Weight loss (decreased appetite) |
| .                                                                                 | Mood swings                         | .                               | Women may stop having periods    |
| Low white blood cells                                                             | Breathlessness                      |                                 |                                  |
| .                                                                                 | .                                   |                                 |                                  |
| *Some people can have a severe allergic reaction to one or more components of CHP |                                     |                                 |                                  |  
chemotherapy.  Signs of this can include skin rashes and itching, a high temperature, shivering, dizziness, headache, and/or breathlessness. Case3413, Main Study Consent

Side effects that are not yet known may also occur.  The side effects of study treatment may be a minor inconvenience or could be severe enough to be life-threatening or cause death.  You will be watched closely for side effects, and the drug will be stopped if unwanted or serious side effects develop.  
There may also be other unknown effects that could harm you (or your embryo or fetus, if you become pregnant or father a child) during the time you take part in the study or after the study has been completed.
Clinical trial: NCT02073097
Section: Procedures
Subsections: 3. Study Procedures|Screening

You must follow the instructions given to you by your study doctor and have the tests and procedures that are part of the study.  It is also important that you tell your doctor about any change in how you are feeling and about all medications you are taking while you are taking part in the study.  
If you choose to take part, you will be given study treatment and have tests done in 21dy cycles for 6 cycles.  The sections below describe the tests, procedures, and study treatment administration that will be done as part of this study.

Screening studies and evaluations will be used to determine the eligibility of each subject for study inclusion. After you sign this informed consent form, screening and baseline tests will be done to see if you can take part in the study and to learn about your health before starting study treatment. All evaluations must be completed < 28 days prior to administration of protocol therapy unless otherwise stated in the study protocol and approved by your physician.  
Informed Consent
.  
.  
. . . .  
.  
.  
Complete physical examination Height and Weight Vital signs including: blood pressure, pulse, respiratory rate and temperature.  
We will ask you about the medications you are taking including prescription medications, over-the-counter (OTC) medications and natural/herbal supplements.  
ECOG Performance Status (this describes how well you are functioning in your dily activities)
Baseline Symptoms Assessment
Case3413, Main Study Consent  
Demographics Medical History
.  
Blood and urine samples will be collected for safety and diagnostic tests, including Hepatitis and tests that make sure your organs are functioning
. .  
nrmally.  
HV testing If you are a female who could become pregnant you will have a pregnancy test.  
Either a blood or urine sample will be taken for this test.  
.  
EKG
•
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MUGA or echocardiogram CT scan of neck, chest, abdomen and pelvis with oral and IV contrast (neck may be omitted at discretion of treating physician). PET/CT scan
. .  
Bone Marrow Aspirate and Biopsy
Clinical trial: NCT02073097
Section: Purpose of Research
Subsections: 2. Purpose

You are being asked to take part in a clinical trial because you have been diagnosed with Diffuse Large B-cell Lymphoma that has never been treated.  
This clinical trial uses a drug called Carfilzomib (C) in combination with Rituximab, Doxorubicin, Vincristine, Cyclophosphamide and Prednisone, a regimen known as R-
CHOP.  Carfilzomib is approved by the FDA as a single drug to treat patients with relapsed and refractory Multiple Myeloma. It is currently being studied in clinical trials like this one to learn more about how it functions as a component of combination therapy with other chemotherapy treatments in patients with Multiple Myeloma. This study is being conducted in order to evaluate how Carfilzomib functions in combination with R-CHOP in patients with newly diagnosed diffuse large B-cell Lymphoma.  
Although Carfilzomib is approved by the FDA for Multiple Myeloma, it is not approved for use in Diffuse Large B-cell Lymphoma (DLBCL).  In this study, Carfilzomib is considered an investigational drug, since it is being testing for indications other than their approved usage by the Food and Drug Administration (FDA).  The purpose of this study is to find out what the side effects are and whether or not Carfilzomib is effective in combination with R-CHOP in patients that have been newly diagnosed with Diffuse Large B-cell Lymphoma. As of July 2019, approximately 4,508 people have received Carfilzomib in Amgensponsored clinical trials and business-partner-sponsored clinical trials..  As of July 2019, approximately 6,582 people have received Carfilzomib in investigator-sponsored trials
(STs). Since it was approved for sale, approximately 128,637 people have been prescribed Carfilzomib (Kyprolis®) for treatment. Case3413, Main Study Consent This study is being done to test if the combination of Carfilzomib and R-CHOP has an effect on cancer in patients with newly diagnosed Diffuse Large B-cell Lymphoma.  The side effects (unwanted effects) of this treatment in patients with Diffuse Large B-cell Lymphoma will also be studied.  It is not known if Carfilzomib in combination with R-
CHOP is better or worse than R-CHOP alone or other treatments. About 50 people will take part in this research study at the Cleveland Clinic and other affiliated institutions.
Clinical trial: NCT02073097
Section: Voluntary Participation
Subsections: 10. Voluntary Participation

Your participation in this research study is voluntary.  Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.  If information generated from this study is published or presented, your identity will not be revealed.  
In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.  
Case3413, Main Study Consent  
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Clinical trial: NCT02073097
Section: Withdrawal from Study
Subsections: Follow-Up (Held At A Minimum Of 6, 12 And 24 Months After Cycle 6, Day 1) Can I Stop Participation In The Study?

The study doctor may stop you from taking part in this study at any time if he/she thinks it is in your best interest, or if you do not follow the study rules.  Your study doctor or Amgen may decide to stop this study for either medical or other reasons at any time without your consent.  Your study doctor will tell you if this happens and will talk to you about other treatment options. You can decide to stop at any time and you may still be treated at your hospital or clinic.  
Tell your study doctor if you are thinking about stopping or decide to stop.  You should talk to the doctor about leaving the study before you decide so that he/she can find out if you are having any side effects from study treatment.  Another reason to tell your doctor that you are thinking about stopping is so that he/she can talk to you about any other treatments that could be helpful to you.  
If you decide to stop being in this study, you will still be asked to come back to the hospital or clinic for the end of treatment tests as described.  You may also be asked to take part in follow-up phone calls and/or visits.  This information is important to make sure that there are no lasting side effects from the study treatment and to see if your cancer got better, stayed the same, or got worse after treatment.  
Physical Examination
.  
Weight
.  
Vital signs including: blood pressure, pulse, respiratory rate and temperature.  
.  
We will ask you about the medications you are taking including prescription
.  
medications, over-the-counter (OTC) medications and natural/herbal supplements.  
You will be instructed to stop taking acyclovir at your 6 month follow up visit.  
•
ECOG Performance Status
.  
We will ask you about any side effects you may be having
.  
Blood samples will be collected in order to see how well your organs are
.  
functioning.  
.  
CT neck/chest/abdomen/pelvis (may omit neck if not deemed clinically indicated by investigator) ECHO will be performed at 6 month follow up visit
.  
Your physician will assess how are your responding to the study drug
.