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Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma

Study acronym: HEME-18
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv12
  2. Study sites: 1 to 2v11
  3. Study Identification, Study Statusv10
  4. Collaborators expanded, about 3 wordsv9 See this version in full on ClinicalTrials.gov ↗
  5. Primary endpoint revised Study description revisedv8 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria shortened, about 9 wordsv7 See this version in full on ClinicalTrials.gov ↗
  2. Study description shortened, about 93 words Eligibility criteria expanded, about 5 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date changed from estimate of Dec 2022 to Jan 5, 2023v5
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  5. Start date: Oct 2022 to Dec 2022v3
  6. Start date: May 31, 2022 to Oct 2022 Secondary endpoints: details revised at 3 of 10 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 3 of 10 entries
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Trial Details
NCT Number NCT05344833
Lead Sponsor University of Illinois at Chicago
Collaborators: Huntsman Cancer Institute
Conditions Multiple Myeloma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov