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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05405387
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Budesonide EC — DRUG
    Subjects will take 3mg of Budesonide or placebo. Dosing will begin on day prior to cell infusion and continue until Day 14 post transplant. Budesonide or placebo will be in capsule formulation. Budesonide or Placebo will be administered orally three times daily (every 8 hours ± 1 hours) with or without food.
  • Placebo — DRUG
    Subjects will take 3mg of Budesonide or placebo. Dosing will begin on day prior to cell infusion and continue until Day 14 post transplant. Budesonide or placebo will be in capsule formulation. Budesonide or Placebo will be administered orally three times daily (every 8 hours ± 1 hours) with or without food.

Study Details

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 Dates

Start date
May 3, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Run-In Phase
    Budesonide EC 3 mg three times a day, oral
  • Experimental: Arm 1: Treatment
    Budesonide EC 3 mg three times a day, oral
  • Placebo Comparator: Arm 2: Placebo
    Placebo 3 mg three times a day, oral

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112
Rachel Kingsford
[email protected]
801-585-0115

Find similar trials in Salt Lake City, UT

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Huntsman Cancer Institute at the University of Utah· Salt Lake City, UT

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