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MInimal Residual Disease Adapted Strategy

Study acronym: MIDAS
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 65 to 73 Primary completion date changed from estimate of Dec 1, 2024 to Sep 30, 2024 · Completion date: Sep 1, 2028 to Sep 30, 2028v5 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 1, 2024 to Sep 30, 2024
    • Completion date: Sep 1, 2028 to Sep 30, 2028
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 716 to confirmed 791 · Site details revised at 65 of 65 sitesv4 Show 2 more changesShow less
    • Enrollment target: estimated 716 to confirmed 791
    • Site details revised at 65 of 65 sites
  3. Study sites: 68 to 65v3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2021 to Dec 8, 2021 · Primary completion date: Sep 1, 2024 to Dec 1, 2024 · Study sites revised (68)v2 Show 3 more changesShow less
    • Start date changed from estimate of Sep 1, 2021 to Dec 8, 2021
    • Primary completion date: Sep 1, 2024 to Dec 1, 2024
    • Study sites revised (68)

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5).
Trial Details
NCT Number NCT04934475
Lead Sponsor Intergroupe Francophone du Myelome
Collaborators: Amgen, Sanofi, Bristol-Myers Squibb
Conditions Multiple Myeloma
Enrollment 791 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov