Clinical Trial

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Study acronym: IFM2021-01
Recruiting Phase 2
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Record status
This record was last updated September 17, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-10-06; most recent amendment 2025-09-10.
Status change: Not Yet Recruiting → Recruiting 2024-07-31
Trial Details
NCT Number NCT05572229
Lead Sponsor University Hospital, Lille
Collaborators: Janssen Pharmaceutica N.V., Belgium
Conditions Multiple Myeloma
Enrollment 74 participants
Start Date 2023-12-21
Primary Completion 2026-04 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-17