Actively Recruiting
Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
Led by University of Utah · Updated on 2026-05-14
120
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with multiple myeloma or plasma cell leukemia and planned for ASCT with melphalan 200 mg/m2 or 140 mg/m2
- Determined fit by investigator for ASCT
- Able and willing to provide informed consent
- Adequate liver function: total bilirubin ≤ 2 times institutional upper limit; AST/ALT ≤ 5 times institutional upper limit
- For females not surgically sterilized: negative pregnancy test or post-menopausal status as defined by specific hormonal or surgical criteria
- For safety run-in cohort only: reserve of at least 2.5 x 10^6 CD34 cells available in case of delayed engraftment
You will not qualify if you...
- Current use of oral budesonide at enrollment
- Receiving other investigational agents unless approved by the principal investigator
- Moderate or severe hepatic impairment per Child-Pugh classification
- History or current diagnosis of inflammatory bowel disease or microscopic colitis
- Prior allogeneic stem cell transplant
- Medical, psychiatric, cognitive, or other conditions affecting consent or study compliance
- Known severe hypersensitivity to melphalan, budesonide, or similar compounds (Grade ≥ 3)
- Use of prohibited medications without required washout period of at least five half-lives or 14 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here