Neoplasms

All Conditions

Infections

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Papilloma

Virus Diseases

Deglutition Disorders

Lip Neoplasms

Oropharyngeal Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Neoplasms

Mouth Diseases

Oral Cancer

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Modified Barium Swallow (MBS)

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing Questionnaire

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom Questionnaire

Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-Strobe Procedure

MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning

Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning

Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Intensity Modulated Radiotherapy (IMRT)

Clifton Fuller, MD, PHD

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.

This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational.

Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Baseline Visit:

If you are found to be eligible to take part in this study and agree, you will have a baseline visit. The following tests and procedures will be performed:

* You will have a hearing test.
* You will have a dental exam. During this exam, your saliva flow will be measured and you will be checked for lockjaw.
* Your swallowing function will be tested with a special type of x-ray called a modified barium swallow (MBS). During the test, you will eat and drink foods and liquids mixed with a "contrast" chemical called barium that will make your throat more visible in the x-rays. A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat.
* You will complete a questionnaire about swallowing that should take about 5 minutes to complete.
* You will have a video-strobe procedure to check your vocal cords. To perform a video-strobe procedure, a small camera will be inserted into the throat through your nose or mouth. You will be awake for this procedure and the study staff will give you the option of receiving a numbing spray for your nose and/or throat.
* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will fill out questionnaires about your quality of life, work status, medical history, smoking status, and any symptoms you may have. Completing these questionnaires should take about 10-15 minutes.

Study Groups:

If you are among the first 15 patients enrolled in the study, you will be in Group 1.

If you join the study after the first 15 patients have enrolled, you will be randomly assigned (as a flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If you are in Group 1, an MRI will be used to plan your IMRT.
* If you are in Group 2, you will receive standard-of-care IMRT.

Length of Study Participation:

No matter which group you are in, you may continue receiving radiation therapy for up to 6 ½ weeks. You will no longer be able to take part in this study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your overall participation on the study will be over after 5 years.

Treatment Planning and Schedule:

You will receive a standard CT simulation which will cover your head and neck for treatment planning. You will also have a PET-CT to check the status of the disease and for treatment planning purposes.

If you are among the first 15 participants or are in Group 1, you also will have an MRI simulation for treatment planning purposes.

All groups will then receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).

Study Visits:

Every week while you are receiving radiation therapy:

* You will have a physical exam.
* Blood (about 1-2 tablespoons) will be drawn for routine tests.
* You will fill out the same questionnaires as before.
* You will have an MRI.

At Weeks 3 and 6:

* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will have a dental exam.

If you are among the first 15 participants or are in Group 1, you will also have the MRI simulation at the end of Weeks 1, 2, 3, and 4 of treatment.

Six (6) weeks after finishing radiation therapy, you will complete the same questionnaires as before.

Within 8-12 weeks after finishing radiation therapy:

* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will have a hearing test.
* If you are among the first 15 participants or are in Group 1, you will have an MRI simulation.

Six (6) months, 1 year, and 2 years after finishing radiation therapy:

* You will fill out the same questionnaires as before.
* You will have a mouth exam to check your swallowing function.
* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will fill out the same questionnaires as before.
* You will have a video-strobe procedure to check your vocal cords.
* At 1 year only, you will have a dental exam and an MBS exam to test your swallowing function.
* At 1 year and 2 years only, you will also have a hearing test.

Three to six (3-6) months, 1 year, and 18-24 months after finishing radiation therapy:

* You will have an MBS exam to test your swallowing function.
* You will fill out the same questionnaires as before.
* You will have the video-strobe procedure to check your vocal cords.

Two (2) years after finishing radiation therapy and if the disease gets worse, blood (about 3 teaspoons) will be drawn for circulating tumor cells (CTCs). This is a test of how many tumor cells are in the blood.

Five (5) years after finishing radiation therapy, you will have an MBS exam to test your swallowing function and will complete the same questionnaires as before.

If the doctor thinks it is needed during follow-up, you will have a tumor biopsy for tumor marker testing and a CT scan, MRI scan and/or PET/CT scan to check the status of the disease.

Follow-Up Calls:

During the 8-12 weeks while you are recovering from treatment, you will be called or emailed by an automated system every 2 weeks.

This will be to remind you to fill out a web-based form that asks about any side effects you may have had. Completing the form should take about 10-15 minutes each time.

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.

Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

These include: 1) PEG tube dependence at last follow-up; 2) trace or frank aspiration seen on modified barium swallow study; 3) diagnosis of aspiration pneumonia; 4) presence of pharyngoesophageal structure on modified barium swallow study or endoscopy with subsequent need for dilation.

Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

Overall survival, calculated as time from diagnosis to either death or last follow-up, with death serving as an event and all others censored.

Progression-free survival, calculated as time from diagnosis to either death or detection of recurrent disease after an interval without radiographic of clinically evident disease (whichever is earlier), with death or recurrence detection serving as an event and all others censored.

Distant metastasis-free survival, calculated as time from diagnosis to either death or detection of disease outside of the head and neck after an interval without radiographic of clinically evident disease (whichever is earlier), with death or metastasis detection serving as an event and all others censored.

Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI)

Physician-reported toxicity, defined as any grade 3-4 adverse events using Common Terminology Criteria for Adverse Events (CTCAE)-4.0.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Heart and Blood Diseases

Heart Failure

Ventricular Dysfunction, Left

Ventricular Dysfunction

Heart Diseases

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Echocardiograms

Electrocardiogram

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Telephone follow-up by study staff at months 3 and 5.

Telephone Follow-Up

Anecita Fadol, PHD, MSN

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.

If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
* You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
* You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
* You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
* You will be given instructions on how to gradually wean yourself off of your heart failure medication.
* You will be given a machine that you will use to measure your blood pressure at home.

You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.

At Month 1:

* You will have a physical exam, including measurement of your vital signs.
* You will complete the questionnaire about any symptoms you may be having.
* You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 2, 4, 6, 12, 18, and 30:

* You will have a physical exam, including measurement of your vital signs.
* You will complete the questionnaire about any symptoms you may be having.
* You will have an ECHO.
* You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 3 and 5, you will have a telephone follow-up with a member of the research team.

Length of Study Participation:

You may continue taking part in the study for up to 6 continuous months with follow-up visits at Months 12, 18, and 30. You will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study.

Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)

A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF\<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, \& 30.

To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.

Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)

Intervention (Weaning)

Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.

Maintenance of LVEF ≥50% after weaning of heart failure medications.

Age, Categorical

Age, Continuous

< 30

>/= 30-39

>/= 40-49

>/= 50-59

>/= 60

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

LVEF ≥50%, taking heart failure medications classified as Angiotension converting enzyme inhibitors (ACE-Inhibitors), Beta-blockers, and/or angiotension-receptor blockers (ARBs), no diabetes, no hypertension, no arrhythmias, cancer in remission for at least 6 months

Left ventricular ejection fraction (LVEF) ≥50%

Patients at MD Anderson that met inclusion criteria (specified in Recruitment Details) and not excluded due to: Cancer recurrence; documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis; presence of HF symptoms (e.g. shortness of breath, edema); Pregnancy.

Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing

Maintained (LVEF </= 50%)

Withdrawal Failure (LVEF <50% or decrease of 10%)

Lost to Follow Up

Withdrawal by Subject

"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"

Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).

The standard deviation is 0 because every value collected over the course of the entire study was 0.03. Mean would be 0.03 with a standard deviation of 0

Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Lenalidomide

Bortezomib

Dexamethasone acetate

BB 1101

Panobinostat

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Induction Starting Doses: Lenalidomide 25 mg orally daily on days 1-14; Bortezomib 1.3 mg/m\^2 intravenous (IV) daily on days 1, 4, 8 and 11; Dexamethasone 20 mg orally daily on days 1, 2, 4, 5, 8, 9, 11, 12 and Panobinostat orally 10 mg on days 1, 3, 5, 8, 10 and 12. Induction therapy consists of 21 day cycle in Part A and 28 day cycle in Part B.

Symptom Questionnaire completed on day 1 of each cycle.

Induction Therapy (Part A, 21-day cycles): 10 mg by mouth on Days 1, 3, 5, 8, 10, and 12 for 2 weeks with 1 week of rest at the end of each cycle.

Induction Therapy (Part B, 28-day cycles): 10 mg by mouth on Days 1, 3, 5, 15, 17, and 19 of every cycle.

Maintenance dose (Part A, 28-day cycles): Maximum tolerated dose (MTD) from Induction phase on Days 1, 3, 5, 8, 10, and 12 of each cycle.

Maintenance dose (Part B, 28-day cycles): Maximum tolerated dose (MTD) from Induction phase on Days 1, 3, 5, 15, 17, 19 of each cycle.

Induction Therapy (Part A, 21-day cycles): 1.3 mg/m\^2 by vein daily on days 1, 4, 8 and 11 of Cycles 1 - 8.

Induction Therapy (Part B, 28-day cycles): 1.3 mg/m\^2 by vein daily on days 1, 8 and 15 of Cycles 1 - 8.

Induction Therapy (Part A, 21-day cycles): 25 mg by mouth daily on days 1-14 of every cycle.

Induction Therapy (Part B, 28-day cycles): 25 mg by mouth daily on days 1-21 of every cycle.

Maintenance dose (Parts A and B, 28-day cycles): Last tolerated dose from Induction Phase on Days 1 - 21 of each cycle.

Induction Therapy (Part A, 21-day cycles): 20 mg by mouth daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of Cycles 1 - 8.

Induction Therapy (Part B, 28-day cycles): 20 mg by mouth daily on Days 1, 2, 8, 9, 15 and 16 of Cycles 1-8.

Maintenance dose (Parts A and B, 28-day cycles): Last tolerated dose from Induction Phase on Days 1, 8, 15, 21 of each cycle.

Elisabet E. Manasanch, MD

The goal of this clinical research study is to find the highest tolerable dose of the drug panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug combination will also be studied.

Panobinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.

Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die.

Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may slow the growth of cancer cells.

Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of panobinostat based on when you join this study.

If you are enrolled in the first portion of Part A, up to 4 dose levels of panobinostat will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of panobinostat is found.

If you are enrolled in the second portion of Part A, you will receive panobinostat at the recommended dose from the first portion of Part A.

If you are enrolled in the first portion of Part B, up to 3 dose levels of panobinostat will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of panobinostat is found.

If you are enrolled in the second portion of Part B, you will receive panobinostat at the recommended dose from the first portion of Part B.

Study Drug Administration:

Induction Therapy (Part A):

In the Induction phase of therapy, each cycle is 21 days.

On Days 1, 4, 8, and 11 of Cycles 1-8, you will receive bortezomib either through a needle under your skin or by vein over 3-5 seconds. You will be watched by the study staff for 30 minutes after the infusion.

On Days 1-14 of every cycle, you will take lenalidomide by mouth 1 time each day. You should swallow the lenalidomide capsules whole with 1 cup (about 8 ounces) of water. Do not break, chew, or open the capsules.

You will take panobinostat by mouth 1 time a day with food on Days 1, 3, 5, 8, 10 and 12 for 2 weeks with 1 week of rest at the end of each cycle.

On Days 1, 2, 4, 5, 8, 9, 11, and 12 of Cycles 1-8, you will take dexamethasone by mouth 1 time a day. After 8 cycles, you may continue to take dexamethasone if the doctor thinks it is needed. Dexamethasone should be taken with food.

Induction Therapy (Part B):

In Part B, the induction phase of therapy is 28-day cycles.

On Days 1, 8, and 15 of Cycles 1-8, you will receive bortezomib either through a needle under your skin or by vein over 3-5 seconds. You will be watched by the study staff for 30 minutes after the infusion.

On Days 1-21 of every cycle, you will take lenalidomide by mouth 1 time each day. You should swallow the lenalidomide capsules whole with 1 cup (about 8 ounces) of water. Do not break, chew, or open the capsules.

You will take panobinostat by mouth 1 time a day with food on Days 1, 3, 5, 15, 17, 19 of every cycle.

On Days 1, 2, 8, 9, 15,16, Cycles 1-8, you will take dexamethasone by mouth 1 time a day. After 8 cycles, you may continue to take dexamethasone if the doctor thinks it is needed. Dexamethasone should be taken with food.

Maintenance Therapy (Parts A and B):

In the Maintenance phase of therapy, each cycle is 28 days.

You will take lenalidomide by mouth 1 time each day on Days 1-21 of each cycle.

You will take dexamethasone by mouth 1 time a day on Days 1, 8, 15, and 21 of each cycle.

In Part A, you will take panobinostat by mouth 1 time a day on Days 1, 3, 5, 8, 10, and 12 of each cycle. In Part B, you will take panobinostat by mouth 1 time a day on Days 1, 3, 5, 15, 17, 19 of each cycle.

Other Instructions:

You can take the study drugs anytime during the day but you should take them at the same time every day.

If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose). If you take more than the prescribed dose of lenalidomide, you should seek emergency medical care if needed and contact the study staff right away.

Your study drug doses may be lowered if you have side effects.

You will be given a drug diary for each cycle to write in to help keep track of your study drug doses. You should bring the drug diary and pill bottles to your study visit at the beginning of each new cycle.

The panobinostat capsule(s) should be swallowed with 1 cup of water. You should try to take the dose at around the same time each day. If you vomit after taking panobinostat, you should not take it again until your next scheduled dose. If you forget to take a dose in the morning, you can take it up to 12 hours later. If you miss a dose for more than 12 hours, you should wait until your next scheduled dose. Do not make up missed doses.

On Day 1 of every new study cycle and Cycle 1, Day 5, you should wait to take your panobinostat until you come to the clinic for study tests. Some of the Day 1 tests need to be performed before dosing.

You need to follow all panobinostat dosing instructions as written. Do not miss any panobinostat capsules. You will be asked to return all unused study drug in the bottles provided, along with empty bottles, on Day 1 of every cycle, starting with Cycle 2. Capsules should not be transferred between bottles at any time. Please do not allow anyone else to handle or touch the study drug.

You can stop anytime after Cycle 4 of Induction to have a stem cell transplant. If you decide with your doctor to delay the transplant, you will still be recommended to have your stem cells collected. You will continue with Induction therapy until you have had 4-8 cycles. After that, you will receive Maintenance therapy.

You will be given other drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits (Part A):

On Day 1 of each cycle:

* You will have a physical exam, including measurement of your vital signs.
* Blood (about 5 tablespoons) will be drawn for routine tests and biomarker testing.
* Blood (about 1 teaspoon) and/or urine will be collected to check the status of the disease. If urine is collected, you will collect the urine over 24 hours. This urine or blood will also be used for a pregnancy test if you are able to become pregnant.
* You will complete the symptom questionnaire.
* You will be asked about any symptoms you may have had and any drugs you may be taking.
* If the doctor thinks it is needed, you will have bone x-rays, an MRI and/or a CT scan to check the status of the disease.

On Days 1 and 5 of Cycle 1, you will have 3 ECGs before the study drug dose and 3 ECGs after the dose.

On Day 1 of Cycles 2-8, you will have 3 ECGs.

On Days 4, 8, and 11 of Cycles 1-8:

°Blood (about 4 tablespoons) will be drawn for routine tests.

At the end of Cycle 8 (or if you are going to have a stem cell transplant, at the end of Cycle 4):

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any symptoms you may have had and any other drugs you may be taking.
* Blood (about 2 tablespoons) will be collected for routine tests.
* Blood (about 1 teaspoon) and/or urine will be collected to check the status of the disease. If urine is collected, you will be asked to collect your urine over 24 hours.
* You will have bone x-rays to check the status of the disease.
* If the disease completely responds to the study drugs, you will have a bone marrow aspiration and/or biopsy to confirm the response.

On Day 1 of Maintenance Therapy, or Cycles 9 and beyond (if you choose to delay stem cell transplant) :

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any symptoms you may have had and any other drugs you may be taking.
* You will complete the symptom questionnaire.
* Blood (about 4 tablespoons) will be drawn for routine tests and biomarker testing.
* Blood (about 1 teaspoon) and/or urine will be collected to check the status of the disease. If urine is collected, you will collect the urine for 24 hours. This urine or blood will also be used for a pregnancy test if you are able to become pregnant.
* If the doctor thinks it is needed, you will have bone x-rays, an MRI and/or a CT scan to check the status of the disease.

Study Visits (Part B):

On Days 8 and 15 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2 and beyond:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any symptoms you may have had and any other drugs you may be taking.
* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* You will have 3 ECGs.

Pregnancy Tests (Parts A and B):

During induction therapy, if you are a woman who is able to become pregnant and you have regular or no periods, you will have a blood (about 1 tablespoon) or urine pregnancy test weekly for the first 21 days and then every 21 days while on therapy (including breaks in therapy). If you are a woman who is able to become pregnant and your cycles are irregular, you will have a blood (about 1 tablespoon) or urine pregnancy test weekly for the first 21 days during then every 11-14 days while on therapy (including breaks in therapy).

During maintenance therapy, if you are a woman who is able to become pregnant and have regular or no menstruation, you must have a pregnancy test every 28 days while on therapy (including breaks in therapy). If you are a woman who is able to become pregnant and your cycles are irregular, you will have a blood (about 1 tablespoon) or urine pregnancy test every 14 days (+/-1 day) and every 28 days.

Length of Treatment:

You may receive induction therapy for up to 8 cycles, followed by maintenance therapy for an additional 2 years. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.

End-of-Treatment Visit:

Within 30 days after your last dose of study drugs:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any symptoms you may be experiencing.
* Blood (about 4 tablespoon) and urine will be collected for routine tests.
* Blood (about 1 teaspoon) and/or urine will be collected to check the status of the disease. If urine is collected, you will collect the urine for 24 hours.
* If the disease completely responds to the study drugs, you will have a bone marrow aspiration and/or biopsy to confirm the response.
* If the doctor thinks it is needed, you will have an MRI and/or a CT scan to check the status of the disease.
* If you are able to become pregnant, you will have a urine or blood (about 1 tablespoon) pregnancy test.

Follow-Up:

Every 3 months (+/-1 month) for the first 2 years after the stem cell transplant and then every 6 months (+/- 2 months) for Years 3 and 4, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 4 tablespoons) and urine will be collected for routine tests.
* If the doctor thinks it is needed, you will also have an MRI and/or a CT scan, x-rays, and/or a bone marrow aspiration and biopsy.

Every 6 months during the first 2 years after you are finished with maintenance therapy, you will be asked how you are doing. This will be done at the clinic or by a phone call from the study staff. If you are called, the calls should take 5-10 minutes.

If the disease gets worse, you will no longer have follow-up.

This is an investigational study. Panobinostat is not FDA approved or commercially available. It is currently being used for research purposes only. Bortezomib is FDA approved and commercially available for the treatment of MM. Lenalidomide is FDA approved and commercially available for the treatment of certain types of myelodysplastic syndrome and for MM. The use of this drug combination to treat MM is investigational.

Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.

Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients

Phase I/Ib Trial of the Efficacy and Safety of Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible Patients With Newly Diagnosed Multiple Myeloma (MM)

Maximum tolerated dose (MTD) defined as highest dose level in which 6 participants have less than 2 instances of dose limiting toxicities (DLT). Toxicities graded in severity according to guidelines outlined in NCI-CTCAE version 4.0. Hematologic and non-hematologic DLTs defined differently, and will be based on experiences that occur during the first cycle of study drug administration.

Response assessed according to the recently published International Uniform Response Criteria for multiple myeloma established by the International Myeloma Working Group (IMWG; Durie et al 2006).

Novartis

Symptoms and General Pathology

Recurrence

Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP).

Participants complete the symptom questionnaire with the help of the research nurse or assistant.

Participants complete the symptom survey alone, or with the help of a research nurse or assistant.

Edmonton Symptom Assessment Scale

After completion of the symptom questionnaire, participants asked if they preferred completing the questionnaire alone, or if they preferred to have a nurse help them answer the questions.

Interview

Eduardo Bruera, MD

The goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire.

If participant agrees to take part in the study, basic information about them will be collected from their medical record (such as their age, gender, ethnicity, religion, diagnosis, marital status, educational level, performance status, and any drugs they may have taken in the past or are currently taking).

Participant will also be given a list of words and asked to read them out loud. The research nurse or assistant will write down if participant pronounced the words correctly. This should take up to 7 minutes.

Participant will then be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If participant is enrolled in Group 1, they will complete the symptom questionnaire alone and then a research nurse or assistant will go over their answers with them.
* If participant is enrolled in Group 2, they will complete the symptom questionnaire with the help of the research nurse or assistant.

After participant has completed the symptom questionnaire, they will be asked if they preferred completing the questionnaire alone or if they preferred to have a nurse help them answer the questions. This should take about 1 minute to answer.

Length of Study:

It should take about 15 minutes total to complete the study. Patient's participation on this study will end after they have completed the symptom questionnaire.

Additional Information:

Participant is taking part in this study alone. Participant's family members will not be in the room with them.

This is an investigational study.

Up to 128 participants will be enrolled in the study. All will take part at MD Anderson.

Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion

Edmonton Symptom Assessment Scale: Time Duration of Self-Completion Versus Assisted-Completion in Advanced Cancer Patient: a Randomized Controlled Trial

Two group t-test used with significance level of 5%, a total of 128 patients (64 patients/group) will give 80% power to detect the difference of 1.5 minutes (4 minutes in Group A vs 5.5 minutes in Group B) in overall time, given a common standard deviation of 3, which corresponds to an effect size of 0.5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer	NCT03224000	Malignant Neopl... Oropharyngeal C...	Modified Barium... Swallowing Ques... Symptom Questio... Video-Strobe Pr... MRI Guided Inte... Standard-of-Car... Intensity Modul...	18 Years -	M.D. Anderson Cancer Center
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)	NCT02543294	Heart Failure Cancer Treatmen...	Echocardiograms Electrocardiogr... Symptom Questio... Telephone Follo...	18 Years -	M.D. Anderson Cancer Center
Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients	NCT01440582	Myeloma	Panobinostat Bortezomib Lenalidomide Dexamethasone Symptom Questio...	18 Years -	M.D. Anderson Cancer Center
Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion	NCT02523378	Advanced Cancer...	Edmonton Sympto... Interview	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for symptom questionnaire