Budesonide's effect on diarrhea in multiple myeloma patients undergoing stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.