← Back to Search

Corticosteroid

Budesonide for Multiple Myeloma (IMPACT Trial)

Phase 2
Recruiting
Led By Ghulam Rehman Mohy-ud-din, MBBS
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Adequate organ function as defined as: Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

IMPACT Trial Summary

This trial is testing if budesonide, a medication used to treat inflammation, can help people with multiple myeloma who are undergoing stem cell transplants.

Who is the study for?
Adults diagnosed with multiple myeloma undergoing autologous stem cell transplant (ASCT) can join this trial. They must be fit for ASCT, have proper liver function, and women of childbearing potential must not be pregnant. Exclusions include prior budesonide use, other investigational drugs without approval, severe liver issues, certain bowel diseases or chronic diarrhea, previous allogeneic stem cell transplant, active brain metastases without stable treatment or hypersensitivity to melphalan or budesonide.Check my eligibility
What is being tested?
The study is testing if Budesonide reduces the occurrence of moderate to severe diarrhea in patients with multiple myeloma who are receiving an autologous stem cell transplant. It's a phase 2 trial where participants will either receive Budesonide EC or a placebo randomly after a run-in period involving 20 patients.See study design
What are the potential side effects?
Budesonide may cause side effects such as immune system suppression leading to increased infection risk; mood swings; high blood pressure; stomach ulcers; bone weakness and fractures; cataracts and glaucoma in the eyes.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have multiple myeloma or Plasma Cell Leukemia and am fit for a stem cell transplant with melphalan.
Select...
My liver is functioning within the required limits.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Communicable Diseases
Diarrhea
Secondary outcome measures
Change in Bristol Stool Scale
Incidence of post ASCT infection prior to engraftment
Length of stay in hospital
+64 more

IMPACT Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Run-In PhaseExperimental Treatment1 Intervention
Budesonide EC 3 mg three times a day, oral
Group II: Arm 1: TreatmentExperimental Treatment1 Intervention
Budesonide EC 3 mg three times a day, oral
Group III: Arm 2: PlaceboPlacebo Group1 Intervention
Placebo 3 mg three times a day, oral

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,102 Previous Clinical Trials
1,779,141 Total Patients Enrolled
6 Trials studying Multiple Myeloma
156 Patients Enrolled for Multiple Myeloma
Ghulam Rehman Mohy-ud-din, MBBSPrincipal InvestigatorHuntsman Cancer Institute

Media Library

Budesonide EC (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05405387 — Phase 2
Multiple Myeloma Research Study Groups: Arm 2: Placebo, Run-In Phase, Arm 1: Treatment
Multiple Myeloma Clinical Trial 2023: Budesonide EC Highlights & Side Effects. Trial Name: NCT05405387 — Phase 2
Budesonide EC (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405387 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to sign up for this experiment?

"No, this research study is not seeking any more participants at the moment. The listing on clinicaltrials.gov shows that the last update to this trial was on October 6th, 2022 and it was originally posted January 15th, 2023. Although this particular trial isn't looking for candidates, there are 902 other trials that are currently still recruiting patients."

Answered by AI

What goals do researchers hope to achieve with this experiment?

"The primary objective of this 18-day clinical trial is to compare the 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) between patients receiving prophylactic budesonide plus standard of care compared to those receiving standard of care. Secondary objectives include The proportion of patients in each arm reporting "frequent" or "almost constant" vomiting on Day 0 of transplant on the PRO-CTCAE score, Median score of EORTC QLQ-C30 in each arm, and Time to eng"

Answered by AI

What is the margin of safety for Budesonide EC?

"There is some clinical data supporting Budesonide EC's safety, but none yet for efficacy. So, it received a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
2023. "Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405387.
~42 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top