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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Length of stay in hospital
To assess the effects of prophylactic budesonide plus SOC compared to SOC
Time to engraftment
To assess the effects of prophylactic budesonide plus SOC compared to SOC
Proportion of patients using supportive anti-diarrheal and pain medications
To assess the effects of prophylactic budesonide plus SOC compared to SOC
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.
Incidence of post ASCT infection prior to engraftment
To assess the effects of prophylactic budesonide plus SOC compared to SOC
Median score of EORTC QLQ-C30 for participants in each arm
To assess the effects of prophylactic budesonide plus SOC compared to SOC
proportion of patients with engraftment syndrome
To assess the impact of budesonide prophylaxis on engraftment syndrome in patients with multiple myeloma undergoing ASCT.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)