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Budesonide for Diarrhea in Multiple Myeloma Patients Undergoing Stem Cell Transplant

This study is testing if a drug called Budesonide can help reduce severe diarrhea in people with multiple myeloma or plasma cell leukemia who are having an autologous stem cell transplant (ASCT). ASCT is a procedure where you receive your own healthy stem cells after high-dose chemotherapy. Participants will either receive Budesonide or a placebo (an inactive pill) three times a day, starting the day before their stem cell infusion and continuing for 14 days after. The study aims to see if Budesonide can lower the number of patients who experience moderate to severe diarrhea and other serious complications like delayed engraftment (when new blood cells start growing). To join, you must be at least 18 years old and have a confirmed diagnosis of multiple myeloma or plasma cell leukemia, and be scheduled for an ASCT. The current status of this study is unclear.

Study design
This is a randomized, placebo-controlled Phase 2 study involving 120 participants. It starts with a safety run-in period for 20 patients before proceeding to the main randomized stage.
What's involved
You would take Budesonide or a placebo capsule orally three times daily from the day before your cell infusion until 14 days after your transplant. You will also report your symptoms using a patient-reported outcome system.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure delayed engraftment and severe infection complications at 18 days. Diarrhea incidence will be measured until 14 days post-transplant.

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NCT05405387

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Utah
~120 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Budesonide ECPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with delayed engraftment (engraftment after day 18) and severe infection related complications (≥ Grade 4 NCI CTCAE v5).
Measured over 18 days
+1 more outcome measured

Conditions

Multiple Myeloma
Plasma Cell Leukemia

Explore related trials

Multiple MyelomaPlasma Cell Leukemia

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Ghulam Rehman Mohy-ud-din, MBBS · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Rachel Kingsford
[email protected]
801-585-0115
Email the study team

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Eligibility criteria

Inclusion

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).
Patient must have at least 2.5 x 106 CD34 cells in reserve for use if engraftment is delayed

Exclusion

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.

What this trial measures

  • Proportion of patients with delayed engraftment (engraftment after day 18) and severe infection related complications (≥ Grade 4 NCI CTCAE v5).18 days

    impact of budesonide prophylaxis on transplant related outcomes in patients with multiple myeloma undergoing ASCT

  • incidence of Grade 2 or higher diarrhea from the time of ASCT until day 14 post ASCT as measured by NCI Common-Terminology Criteria (CTCAE).14 days

    impact of budesonide prophylaxis plus standard of care (SOC) versus standard of care (SOC) alone on the incidence of ≥ Grade 2 diarrhea (NCI CTCAE v5) in multiple myeloma patients receiving high-dose melphalan in preparation for ASCT