A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Summary

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Timeline

Start

2023-03-29

Primary completion

2025-10-13

Completion

2031-08-31

Outcome

Met primary endpoint

paper teclistamab significantly improved progression-free survival as compared with PVd or Kd (estimated 18-month progression-free survival, 69.8% vs. 26.9% PMID 42212933 ↗

release “Phase 3 MajesTEC-9 study of TECVAYLI®(teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death” jnj.com ↗

Publications

• Touzeau C, Mina R, Quach H, Hungria V, Bhutani D, Chen W, Kumar S, Chaulagain C, Dimopoulos MA, Bahlis NJ, Maral S, van de Donk NWCJ, Schmidt Filho J, Saja K, Teipel R, Ando M, Roeloffzen W, Annibali O, Augustson B, Botta C, Delforge M, Bourgeois E, Buda G, Hus M, Perrot A, Preis M, Beksac M, Pour L, Farmer S, Nunes M, Oriol A, Melchardt T, Hu Y, Flogegard M, Wang D, Pei L, Wroblewski S, Aries IM, Quijano Carde NA, Perova T, de Jager T, Yeh TM, Vanquickelberghe V, Shah P, Chastain K, Kobos R, Carson R, Landgren O; MajesTEC-9 Trial Investigators. Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy. N Engl J Med. 2026 May 29. doi: 10.1056/NEJMoa2603870. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	—	Subcutaneous
Subject	Carfilzomib	Other / unclassified	—	Intravenous
Subject	Pomalidomide	Other / unclassified	—	Oral
Subject	Teclistamab	Monoclonal antibody	—	Subcutaneous
Background	Dexamethasone	Small molecule	—	Oral

Indications