Phase 2 Study of Budesonide to Reduce Moderate to Severe Diarrhea in Adults with Multiple Myeloma Undergoing Autologous Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the use of budesonide in patients with multiple myeloma or plasma cell leukemia undergoing autologous stem cell transplant ASCT. This phase 2 randomized, placebo-controlled trial aims to study the impact of budesonide on the incidence of grade 2 or higher diarrhea and other complications following the transplant. The study begins with a safety run-in phase involving 20 patients to monitor delayed engraftment and infection rates. Participants will either receive budesonide or a placebo, both given orally at a dose of 3 mg three times daily, starting the day before cell infusion and continuing until 14 days after transplant. After the safety run-in, 100 patients will be randomized equally to either the budesonide or placebo group. Throughout the trial, patients report symptoms using the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events PRO-CTCAE. During the study, participants will be closely monitored for safety and effectiveness measures including delayed engraftment, infection rates, diarrhea severity, abdominal pain, nausea, vomiting, and other symptoms. Assessments include PRO-CTCAE questionnaires at various time points from before transplant up to three months post-transplant. The study also tracks hospital stay length, medication use, stool consistency, and quality of life. Participation involves follow-up visits and symptom reporting for up to three months after ASCT.

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