Budesonide EC for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT
Multiple Myeloma+2 More
Budesonide EC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A randomized placebo controlled, phase 2 study of budesonide in subjects with multiple myeloma undergoing autologous stem cell transplant. The study includes a run-in period with 20 patients.

Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 21 Secondary · Reporting Duration: up to 30 days

18 days
Proportion of patients with delayed engraftments (engraftment after day 18) and severe infection related complications (≥ Grade 4 NCI CTCAE v5).
6 weeks
Median score of EORTC QLQ-C30 for participants in each arm
Median score of EORTC QLQ-C30 in each arm
Day 0
The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 0 of transplant on the PRO-CTCAE score.
proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day 0 of transplant on the PRO-CTCAE score
proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 0 of transplant on the PRO-CTCAE score
proportion of patients reporting "frequent" or "almost constant" diarrhea on Day 0 of transplant on the PRO-CTCAE score
Day 14
The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 14 of transplant on the PRO-CTCAE score.
proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day 14 of transplant on the PRO-CTCAE score
proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 14 of transplant on the PRO-CTCAE score
proportion of patients reporting "frequent" or "almost constant" diarrhea on Day 14 of transplant on the PRO-CTCAE score
Day 7
The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 7 of transplant on the PRO-CTCAE score.
proportion of patients in each arm reporting "frequent" or "almost constant" abdominal pain on Day 7 aof transplant on the PRO-CTCAE score
proportion of patients in each arm reporting "frequent" or "almost constant" nausea on Day 7 of transplant on the PRO-CTCAE score
proportion of patients reporting "frequent" or "almost constant" diarrhea on Day 7 of transplant on the PRO-CTCAE score
up to 18 days
incidence of Grade 2 or higher diarrhea from the time of ASCT until the third day of engraftment as measured by NCI Common-Terminology Criteria (CTCAE).
up to 30 days
Change in Bristol Stool Scale.
Incidence of post ASCT infection prior to engraftment
Length of stay in the hospital
Proportion of patients using supportive anti-diarrheal and pain medications.
Time to engraftment
Use of supportive anti-diarrheal and pain medications.
proportion of patients with engraftment syndrome

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Arm 1: Treatment
1 of 3
Run-In Phase
1 of 3
Arm 2: Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

120 Total Participants · 3 Treatment Groups

Primary Treatment: Budesonide EC · Has Placebo Group · Phase 2

Arm 1: Treatment
Drug
Experimental Group · 1 Intervention: Budesonide EC · Intervention Types: Drug
Run-In Phase
Drug
Experimental Group · 1 Intervention: Budesonide EC · Intervention Types: Drug
Arm 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days
Closest Location: Huntsman Cancer Institute at the University of Utah · Salt Lake City, UT
Photo of Salt Lake City 1Photo of Salt Lake City 2Photo of Salt Lake City 3
2008First Recorded Clinical Trial
3 TrialsResearching Multiple Myeloma
12 CompletedClinical Trials

Who is running the clinical trial?

University of UtahLead Sponsor
976 Previous Clinical Trials
1,765,389 Total Patients Enrolled
5 Trials studying Multiple Myeloma
92 Patients Enrolled for Multiple Myeloma
Ghulam Rehman Mohy-ud-din, MBBSPrincipal InvestigatorHuntsman Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have AST/ALT ratio of ≤ 5× institutional ULN.
You are able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Total bilirubin ≤ 2 x institutional ULN.
You are aged ≥ 18 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.