RecruitingMultiple MyelomaPlasma Cell Leukemia

Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: University of Utah

You may qualify if…

✓ 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.
✓ Adequate organ function as defined as:
✓ -Hepatic:
✓ Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN).
✓ AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
✓ For female subjects who have not undergone surgical sterilization: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:

You may not qualify if…

✕ 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.
✕ Prior history of receiving an allogenic stem cell transplant
✕ Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
✕ Known prior severe hypersensitivity to melphalan or budesonide or any component in their formulations or compounds of similar composition (NCI CTCAE v5.0 Grade ≥ 3).
✕ Subjects taking prohibited medications as described in Section 6.6.1. A washout period of prohibited medications for a period of at least five half-lives or 14 days (whichever is shorter) should occur before the start of treatment.

Where it's recruiting

Utah

Salt Lake City

Source: ClinicalTrials.gov · NCT05405387 · last updated 2026-06-05