Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
Qualifiers
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.
Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN).
Disqualifiers
Ongoing or current use of oral budesonide at the time of enrollment.
Receiving other investigational agents, unless deemed acceptable after consultation with the PI
Subjects with moderate or severe pre-existing hepatic impairment as classified according to the Child-Pugh system.
Prior history or current diagnosis of inflammatory bowel disease, microscopic colitis at baseline.
Trial design
Treatments tested in this trial
- Budesonide EC
- Placebo
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov