RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-09

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05405387

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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).	* 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.

Inclusion Criteria

Exclusion 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:
* 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).

* 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.

Contacts and Locations

Study Contact

Catherine Cromar

CONTACT

801-213-5652

catherine.cromar@hci.utah.edu

Principal Investigator

Ghulam Rehman Mohy-ud-din, MBBS

PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Study Locations (Sites)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Ghulam Rehman Mohy-ud-din, MBBS, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-09

Study Completion Date2027-02

Study Record Updates

Study Start Date2023-02-09

Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

Multiple Myeloma