MajesTEC-9

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1006875

• Contact name

  David Wright

• Contact email

  rsorathi@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2022-000928-37

• Research summary

  Multiple myeloma (MM) is a blood cancer that affects certain types of white blood cells called plasma cells. Although treatments are available, MM can reoccur or be resistant to standard treatment.
  Teclistamab (JNJ-64007957) is a modified *antibody that binds to T cell and BCMA (B cell maturation **antigen) present on plasma cell resulting in T cell activation and breakdown of BCMA cells, leading to cell death.
  *a protein that helps protect body against foreign matter, such as bacteria and viruses.
  **a protein on cell surface.
  The study is designed to assess if treatment with teclistamab as single therapy will keep participants’ cancer from getting worse for a longer period as compared to combination therapy of pomalidomide, bortezomib, dexamethasone (PVd) or carfilzomib, dexamethasone (Kd).

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  23/EE/0030

• Date of REC Opinion

  11 Jul 2023

• REC opinion

  Further Information Favourable Opinion