Phase 2 Myeloma Trial, Recruiting NCT05405387 Sponsor: University of Utah Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT05405387
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have been diagnosed with multiple myeloma and/or plasma cell leukemia (confirmed by tissue testing) and are scheduled to receive an autologous stem cell transplant (a transplant using their own stem cells), and whose doctor considers them fit enough for the procedure with a specific chemotherapy preparation drug (melphalan)
  • People who are willing and able to understand the study information and sign a consent form
  • People whose liver is functioning within acceptable limits based on specific blood test results (confirm with trial site for exact values)
  • Women who have not had surgical sterilization must have a negative pregnancy test or confirmed post-menopausal status, based on specific age-related criteria around menstrual history, hormone levels, or prior surgery (confirm with trial site for full details)
  • People enrolling in a specific early safety group of the trial must have a sufficient reserve of a particular type of stem cell available as a backup (confirm with trial site)

Who may not be able to join:

  • People currently taking oral budesonide (a type of steroid medication) at the time of enrolment
  • People currently taking part in another clinical trial or using other experimental treatments, unless the lead trial doctor considers it acceptable
  • People with moderate or severe pre-existing liver disease, as measured by a standard liver health scoring system
  • People with a history of or current diagnosis of inflammatory bowel disease or microscopic colitis
  • People who have previously received a stem cell transplant using someone else's cells (an allogeneic transplant)
  • People with medical, mental health, cognitive, or other conditions that may affect their ability to understand the study, give consent, or follow the study requirements
  • People with a known history of a severe allergic reaction to melphalan or budesonide, or to similar compounds
  • People taking certain medications that are not permitted in this trial — a period of time without those medications is required before joining (confirm with trial site for specific medications and timeframes)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ghulam Rehman Mohy-ud-din, MBBS, Huntsman Cancer Institute

Phone: 801-585-0115

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
3 May 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of patients with delayed engraftment (engraftment after day 18) and severe infection related complications (≥ Grade 4 NCI CTCAE v5).; incidence of Grade 2 or higher diarrhea from the time of ASCT until day 14 post ASCT as measured by NCI Common-Terminology Criteria (CTCAE).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov