NCT05405387 Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
| NCT ID | NCT05405387 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-05-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Ghulam Rehman Mohy-ud-din, MBBS
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute
Frequently Asked Questions
Who can join the NCT05405387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05405387 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05405387 currently recruiting?
Yes, NCT05405387 is actively recruiting participants. Contact the research team at rachel.kingsford@hci.utah.edu for enrollment information.
Where is the NCT05405387 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT05405387 clinical trial?
NCT05405387 is sponsored by University of Utah. The principal investigator is Ghulam Rehman Mohy-ud-din, MBBS at Huntsman Cancer Institute. The trial plans to enroll 120 participants.