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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject aged ≥ 18 years.
  • - History of histologically confirmed multiple myeloma 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:

  • - Prior use of budesonide for any medical condition.
  • - 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 or chronic diarrhea at baseline.
  • - Prior history of receiving an allogenic stem cell transplant.
  • - Current evidence or diagnosis of microscopic colitis or chronic diarrhea at time of screening.
  • - History of other malignancies with the exception of malignancies for which all treatment was completed ≥ 2 years before study enrollment and are considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration.
  • - Known active brain metastases or cranial epidural disease.
--Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05405387
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Utah
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ghulam Rehman Mohy-ud-din, MBBS
Principal Investigator Affiliation Huntsman Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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 all 20 of the patients in the safety run-in have completed follow-up for delayed engraftment (18 days), if the trial is not stopped for a safety signal, then the trial will proceed to a randomized stage. 50 patients will be randomized to placebo and 50 patients will be randomized to budesonide. Patients in both arms will report toxicities by responding to items from the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE.) PRO-CTCAE is a patient-reported outcome (PRO) measurement system used to evaluate symptomatic toxicity in patients on cancer clinical trials based on symptom frequency, severity, interference, amount, and presence/absence. PRO-CTCAE responses are scored from 0 (absent) to 4 (very frequent, severe, etc.), or 0/1 for absent/present.

Arms & Interventions

Arms

Experimental: Run-In Phase

Budesonide EC 3 mg three times a day, oral

Experimental: Arm 1: Treatment

Budesonide EC 3 mg three times a day, oral

Placebo Comparator: Arm 2: Placebo

Placebo 3 mg three times a day, oral

Interventions

Drug: - Budesonide EC

Subjects will take 3mg of Budesonide or placebo starting on day of cell infusion through 3 days post date of engraftment. Budesonide or placebo will be in capsule formulation. Budesonide or Placebo will be administered orally three times daily (every 8 hours ± 1 hours) with or without food.

Drug: - Placebo

Subjects will take 3mg of Budesonide or placebo starting on day of cell infusion through 3 days post date of engraftment. Budesonide or placebo will be in capsule formulation. Budesonide or Placebo will be administered orally three times daily (every 8 hours ± 1 hours) with or without food.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112

Site Contact

Catherine Cromar

catherine.cromar@hci.utah.edu

801-213-5652