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Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Study acronym: IFM2021-01
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Apr 2026 → Jun 2027
See other at-risk trials from University Hospital, Lille

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 2026 to Jun 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites reduced: 29 → 22 locations
    • Study completion pushed from Sep 2030 to Sep 2032
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 3 of 12 entries
  2. Primary completion date: May 2025 to Apr 2026
    • Site details revised at 9 of 29 sites
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 29
    • Start date changed from estimate of Sep 2023 to Dec 21, 2023
    v3
  4. Primary completion date: Feb 2030 to May 2025v2 Show 6 more changesShow less
    • Start date: Feb 2023 to Sep 2023
    • Enrollment target: 82 to 74
    • Study completion date: Feb 2030 to Sep 2030
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints revised (12)
    • Collaborators expanded, about 4 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
Trial Details
NCT Number NCT05572229
Lead Sponsor University Hospital, Lille
Collaborators: Janssen Pharmaceutica N.V., Belgium
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov