Budesonide's effect on diarrhea in multiple myeloma patients undergoing stem cell transplant
A Randomized Phase 2 Trial Investigating the Impact of Budesonide Prophylaxis on Incidence of ≥ Grade 2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
This study is testing if budesonide can help reduce diarrhea in multiple myeloma patients who are getting a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05405387 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial investigates the impact of budesonide on the incidence of grade 2 or higher diarrhea in patients with multiple myeloma undergoing autologous stem cell transplant. The study begins with a safety run-in involving 20 patients to monitor for any safety signals related to engraftment and infection rates. If no safety concerns arise, the trial will proceed to a randomized phase where 100 patients will be split into two groups, receiving either budesonide or a placebo. Patient-reported outcomes will be collected to assess the severity and frequency of toxicities experienced during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of multiple myeloma or plasma cell leukemia who are fit for autologous stem cell transplant.
Not a fit: Patients who are not undergoing autologous stem cell transplant or those with contraindications to budesonide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce the incidence of severe diarrhea in multiple myeloma patients undergoing stem cell transplant, improving their overall treatment experience.
How similar studies have performed: While this approach is novel in the context of multiple myeloma and stem cell transplant, similar studies have shown promise in managing treatment-related toxicities in other cancer populations.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Ghulam Rehman Mohy-ud-din, MBBS — Huntsman Cancer Institute
- Study coordinator: Rachel Kingsford
- Email: rachel.kingsford@hci.utah.edu
- Phone: 801-585-0115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.