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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 27, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2027

Conditions
Multiple Myeloma
Interventions
DRUG

Budesonide EC

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.

DRUG

Placebo

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.

Trial Locations (1)

84112

RECRUITING

Huntsman Cancer Institute at the University of Utah, Salt Lake City

All Listed Sponsors
lead

University of Utah

OTHER