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A randomized placebo controlled, phase 2 study of budesonide in subjects with multiple myeloma undergoing autologous stem cell transplant (ACST). The study includes a run-in period with 20 patients.
The trial will initiate with a safety run-in of 20 pts with a ≥ 5 pts failing to engraft (or having a Grade 4 or higher infection rate) within 18 days as the flag for a potential safety signal.
After all 20 of the patients in the safety run-in have completed follow-up for delayed engraftment (18 days), if the trial is not stopped for a safety signal, then the trial will proceed to a randomized stage. 50 patients will be randomized to placebo and 50 patients will be randomized to budesonide.
Patients in both arms will report toxicities by responding to items from the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE.) PRO-CTCAE is a patient-reported outcome (PRO) measurement system used to evaluate symptomatic toxicity in patients on cancer clinical trials based on symptom frequency, severity, interference, amount, and presence/absence. PRO-CTCAE responses are scored from 0 (absent) to 4 (very frequent, severe, etc.), or 0/1 for absent/present.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Run-In Phase | Experimental | Budesonide EC 3 mg three times a day, oral |
|
| Arm 1: Treatment | Experimental | Budesonide EC 3 mg three times a day, oral |
|
| Arm 2: Placebo | Placebo Comparator | Placebo 3 mg three times a day, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide EC | Drug | Subjects will take 3mg of Budesonide or placebo. Dosing will begin on day prior to cell infusion and continue until Day 14 post transplant. Budesonide or placebo will be in capsule formulation. Budesonide or Placebo will be administered orally three times daily (every 8 hours ± 1 hours) with or without food. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with delayed engraftment (engraftment after day 18) and severe infection related complications (≥ Grade 4 NCI CTCAE v5). | impact of budesonide prophylaxis on transplant related outcomes in patients with multiple myeloma undergoing ASCT | 18 days |
| incidence of Grade 2 or higher diarrhea from the time of ASCT until day 14 post ASCT as measured by NCI Common-Terminology Criteria (CTCAE). | impact of budesonide prophylaxis plus standard of care (SOC) versus standard of care (SOC) alone on the incidence of ≥ Grade 2 diarrhea (NCI CTCAE v5) in multiple myeloma patients receiving high-dose melphalan in preparation for ASCT | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients reporting "frequent" or "almost constant" diarrhea on Day -1 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing diarrhea as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day -1 |
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Inclusion Criteria:
Subject aged ≥ 18 years.
History of histologically confirmed multiple myeloma and/or Plasma Cell Leukemia diagnosis undergoing ASCT who are determined to be fit by the investigator to undergo ASCT with melphalan 200 mg/m2 or melphalan 140 mg/m2 as conditioning.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Adequate organ function as defined as:
--Hepatic:
For female subjects who have not undergone surgical sterilization: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
Women < 50 years of age:
Women ≥ 50 years of age:
Inclusion Criteria required for Patients Enrolling in Safety Run-In Cohort only:
-Patient must have at least 2.5 x 106 CD34 cells in reserve for use if engraftment is delayed
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Kingsford | Contact | 801-585-0115 | rachel.kingsford@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ghulam Rehman Mohy-ud-din, MBBS | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute at the University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Stage one is open-label safety run-in. Stage 2 is randomized, placebo-controlled.
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To preserve the blind, only the Investigational Drug Services Pharmacy personnel and Data Safety Monitoring Committee (DSMC) at Huntsman Cancer Institute will know treatment assignments.
|
|
| Placebo | Drug | Subjects will take 3mg of Budesonide or placebo. Dosing will begin on day prior to cell infusion and continue until Day 14 post transplant. Budesonide or placebo will be in capsule formulation. Budesonide or Placebo will be administered orally three times daily (every 8 hours ± 1 hours) with or without food. |
|
| proportion of patients reporting "frequent" or "almost constant" diarrhea on Day 7 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing diarrhea as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 7 |
| proportion of patients reporting "frequent" or "almost constant" diarrhea on Day 14 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing diarrhea as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 14 |
| proportion of patients reporting "frequent" or "almost constant" diarrhea on Day 30 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing diarrhea as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 30 |
| proportion of patients reporting "frequent" or "almost constant" diarrhea 3 months post ACST on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing diarrhea as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | 3 Months |
| proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day -1 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day -1 |
| proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day 7 aof transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 7 |
| proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day 14 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 14 |
| proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day 30 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 30 |
| proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain 3 months post ACST on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | 3 months |
| proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 1 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day -1 |
| proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 7 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 7 |
| proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 14 of transplant on the PRO-CTCAE score | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 14 |
| The proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 30 of transplant on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 30 |
| The proportion of patients in each arm reporting "frequent" or "almost constant" nausea 3 months post ACST on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | 3 months |
| The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 1 of transplant on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day -1 |
| The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 7 of transplant on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 7 |
| The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 14 of transplant on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 14 |
| The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 30 of transplant on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | Day 30 |
| The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting 3 months post ACST on the PRO-CTCAE score. | To demonstrate the superiority of prophylactic budesonide plus standard of care compared to standard of care in reducing alternative gastrointestinal (GI) toxicities (e.g. abdominal pain, nausea) as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (GI domain, fatigue, mouth sore, concentration, and memory) | 3 months |
| Length of stay in hospital | To assess the effects of prophylactic budesonide plus SOC compared to SOC | up to 30 days |
| Time to engraftment | To assess the effects of prophylactic budesonide plus SOC compared to SOC | up to 30 days |
| Proportion of patients using supportive anti-diarrheal and pain medications | To assess the effects of prophylactic budesonide plus SOC compared to SOC | up to 30 days |
| Change in Bristol Stool Scale | To assess the effects of prophylactic budesonide plus SOC compared to SOC. Scale range is Type 1 to Type 7. A normal stool should be a type 3 or 4, and depending on the normal bowel habits of the individual, should be passed once every one to three days. Type 1 has spent the longest time in the bowel and type 7 the least time. | up to 30 days |
| Incidence of post ASCT infection prior to engraftment | To assess the effects of prophylactic budesonide plus SOC compared to SOC | up to 30 days |
| Median score of EORTC QLQ-C30 for participants in each arm | To assess the effects of prophylactic budesonide plus SOC compared to SOC | 6 weeks |
| proportion of patients with engraftment syndrome | To assess the impact of budesonide prophylaxis on engraftment syndrome in patients with multiple myeloma undergoing ASCT. | up to 30 days |
| Proportion of patients reporting none, mild, moderate, severe or very severe mouth sores as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, mild, moderate, severe or very severe mouth sores as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, mild, moderate, severe or very severe mouth sores as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, mild, moderate, severe or very severe mouth sores as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, mild, moderate, severe or very severe mouth sores as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very mouth interference with daily activity as a result of their mouth sores as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very mouth interference with daily activity as a result of their mouth sores as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very mouth interference with daily activity as a result of their mouth sores as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very mouth interference with daily activity as a result of their mouth sores as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very mouth interference with daily activity as a result of their mouth sores as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with concentration as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with concentration as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with concentration as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with concentration as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with concentration as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of concentration problems as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of concentration problems as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of concentration problems as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of concentration problems as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of concentration problems as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with memory as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with memory as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with memory as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with memory as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, mild, moderate, severe or very severe problems with memory as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of problems with memory as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of problems with memory as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of problems with memory as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of problems with memory as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of problems with memory as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, mild, moderate, severe or very severe fatigue as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, mild, moderate, severe or very severe fatigue as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, mild, moderate, severe or very severe fatigue as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, mild, moderate, severe or very severe fatigue as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, mild, moderate, severe or very severe fatigue as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of fatigue as measured by PRO-CTCAE on Day -1 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day -1 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of fatigue as measured by PRO-CTCAE on Day 7 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 7 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of fatigue as measured by PRO-CTCAE on Day 14 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 14 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of fatigue as measured by PRO-CTCAE on Day 30 | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | Day 30 |
| Proportion of patients reporting none, a little bit, somewhat, quite a bit or very much interference with daily activity as a result of fatigue as measured by PRO-CTCAE 3 months post ACST | descriptively assess in both the prophylactic budesonide arm and the standard of care arms the following toxicities as measured by Patient-Reported Outcome Common Terminology Criteria (PRO-CTCAE) (fatigue, mouth sores, concentration, and memory) | 3 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007938 | Leukemia |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |