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

Study acronym: IMPACT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from May 19, 2026 to Dec 2026 Completion pushed from Sep 2027 to Mar 2028v14 Show 1 more changeShow less
    • Completion pushed from Sep 2027 to Mar 2028
  2. Eligibility criteria expanded, about 9 wordsv13 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Suspended to Recruiting Site details revisedv12 Show 1 more changeShow less
    • Site details revised
  4. Trial status: Recruiting to Suspended Sponsor's reason: DSMC Finding Primary completion date: Jan 2026 to May 19, 2026 · Start date: Apr 27, 2023 to May 3, 2023 · Site details revisedv11 Show 3 more changesShow less
    • Primary completion date: Jan 2026 to May 19, 2026
    • Start date: Apr 27, 2023 to May 3, 2023
    • Site details revised
  5. Primary completion date: Sep 2025 to Jan 2026v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Feb 2025 to Sep 2025 Start date: Feb 9, 2023 to Apr 27, 2023 · Completion date: Feb 2027 to Sep 2027v9 Show 2 more changesShow less
    • Start date: Feb 9, 2023 to Apr 27, 2023
    • Completion date: Feb 2027 to Sep 2027
  2. Eligibility criteria shortened, about 112 wordsv8 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2023 to Feb 9, 2023 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2023 to Feb 9, 2023
    • Site details revised
  5. Primary completion date: Aug 15, 2025 to Feb 2025 Completion date: Aug 15, 2027 to Feb 2027 · Start date: Jan 15, 2023 to Feb 2023v5 Show 2 more changesShow less
    • Completion date: Aug 15, 2027 to Feb 2027
    • Start date: Jan 15, 2023 to Feb 2023
  6. Primary endpoints revised (2) Eligibility criteria expanded, about 13 words · Secondary endpoints: 19 to 67 · Study description expanded, about 80 wordsv4 Show 3 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 19 to 67
    • Study description expanded, about 80 words

    See this version in full on ClinicalTrials.gov ↗

  7. Start date: Sep 15, 2022 to Jan 15, 2023 Primary completion date: Sep 15, 2025 to Aug 15, 2025v3 Show 1 more changeShow less
    • Primary completion date: Sep 15, 2025 to Aug 15, 2025
  8. Secondary endpoints revised (19)v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Utah
302 trials monitored
See 17 trials at risk
Leukemia
2,566 trials monitored
See 143 trials at risk
Multiple Myeloma
1,231 trials monitored
See 77 trials at risk
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.
Trial Details
NCT Number NCT05405387
Lead Sponsor University of Utah
Conditions Multiple Myeloma, Plasma Cell Leukemia
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov