Trial Profile

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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At a glance

Drugs Teclistamab (Primary) ; Bortezomib; Carfilzomib; Dexamethasone; Dexamethasone; Pomalidomide
Indications Multiple myeloma
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms MajesTEC-9
Sponsors Janssen Research & Development; Janssen-Cilag

29 Oct 2024 Primary end-points have been updated to add a safety end-point- "Number of Participants Reporting Cytokine Release Syndrome" thus making "AR" also a trial focus.
29 Oct 2024 Planned number of patients changed from 590 to 650.
29 Oct 2024 Planned primary completion date changed from 14 Oct 2025 to 13 Feb 2026.

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