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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Multiple Myeloma, Plasma Cell Leukemia

In brief

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.

Key facts

Study ID

NCT05405387

Run by

University of Utah

People needed

120

Starts

2023-05-03

Expected to finish

2028-03-01

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Women < 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
• Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
• Women ≥ 50 years of age:
• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
• Had radiation-induced menopause with last menses >1 year ago; or
• Had chemotherapy-induced menopause with last menses >1 year ago; or
• Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
• Inclusion Criteria required for Patients Enrolling in Safety Run-In Cohort only:
• Patient must have at least 2.5 x 106 CD34 cells in reserve for use if engraftment is delayed

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 is running

• Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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