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Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience.

If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms.

Subject will receive 5 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form.

If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4.

High dose dexamethasone

Subject will receive 1 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form.

If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4.

Low dose dexamethasone

Ute Bartels, MD

The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.

Dexamethasone is an effective medication to ameliorate radiation induced headache and vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient in treating these symptoms. However this experience is not shared from many neuro-oncology centers of excellence that more commonly use 5 mg/m2/day according to the results of the trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of dexamethasone in different dose regimens in symptomatic children while undergoing CNS radiation will elucidate the appropriate dose.

Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION

The primary outcome will be the evaluation of effectiveness of dexamethasone on vomiting after 24-48 hours (after 2-4 doses of treatment). Vomiting is defined as either retching or vomiting and will be counted in events. The frequency of emetic episodes/day will be documented in the daily diary. The effectiveness of dexamethasone will be counted in number of episodes and evaluated on day 2 (48 hours after first dose).

Parent/patients are asked to document the worst headache of the day prior to bedtime daily on a visual analogue scale using the 6-face "happy face" scale ranging from 0 (no headache) to 5 (extreme headache).

These will be described with numbers, type and frequencies for the duration of the subjects participation in the study.

Parent/patient will complete a quality of life assessment within 14 days prior to starting radiation (including first day of radiation) and within 14 days post completion of radiation (including last day of radiation).

C17 Council

The Hospital for Sick Children

Staff Physician

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Pomalidomide

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Combination Pomalidomide, low-dose Dexamethasone, and Marizomib:

Oral Pomalidomide, days 1-21 of 28 day cycle, dose 3 to 4 mg

pomalidomide

IV Marizomib, 0.2 to 0.5 mg/m2 on days 1, 4, 8, 11 of 28 day cycle

marizomib

Oral Dexamethasone, days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23 of 28 day cycle, 5 or 10 mg

low-dose dexamethasone

Steven D Reich, MD

This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:

* Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of multiple myeloma.
* Marizomib is an investigational drug being developed by Triphase that is being studied for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet been approved by health authorities, such as the FDA, for general use but have been approved for use in specific clinical studies. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome inhibitors have been shown to be effective in the treatment of multiple myeloma.
* Dexamethasone is a corticosteroid drug that affects the immune system (an immunomodulatory drug) that has been approved by the FDA for the treatment of multiple myeloma.

This is the first study to evaluate the three-drug combination of pomalidomide (POM), marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory multiple myeloma.

The primary objective of this study is to determine the best drug dosing levels for this three-drug combination, including the highest safe doses and/or the recommended doses for future clinical studies of this drug combination. The secondary purposes of this study are to determine the safety of this drug combination and its effectiveness in treating relapsed or refractory multiple myeloma. The study will include examination of levels of all three drugs in the blood during various time points during treatment.

Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma

A Phase 1, Multicenter, Open-label, Dose-Escalation Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Celgene Corporation

Celgene

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation	NCT01135550	Vomiting Headache	High dose dexam... Low dose dexame...	2 Years - 18 Years	The Hospital for Sick Children
Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma	NCT02103335	Multiple Myelom... Refractory Mult... Multiple Myelom...	pomalidomide marizomib low-dose dexame...	18 Years -	Celgene

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