Status:
SUSPENDED
Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
Lead Sponsor:
University of Utah
Conditions:
Multiple Myeloma
Plasma Cell Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
The trial will initiate with a safety run-in of 20 pts with a ≥ 5 pts failing to engraft (or having a Grade 4 or higher infection rate) within 18 days as the flag for a potential safety signal. After...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05405387
Start Date
May 3 2023
End Date
September 1 2027
Last Update
December 3 2025
Active Locations (1)
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1
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112