MonumenTAL-6

• Research type

  Research Study

• Full title

  A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide

• IRAS ID

  1008541

• Contact name

  David Wright

• Contact email

  cmeyer8@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2022-502446-27

• ISRCTN Number

  ISRCTN74178658

• Research summary

  Multiple myeloma is a blood cancer that affects certain types of white blood cells called plasma cells. Although treatments are available, multiple myeloma can come back after treatment or be resistant to standard treatment. Drugs that redirect T cells (a type of white blood cells) to attack cancer cells may be an effective means to destroy cancer cells leading to a long-term treatment response.
  Talquetamab (also known as JNJ-64407564 or Tal or TALVEY) and teclistamab (JNJ-64007957 or Tec or TECVAYLI) are modified antibodies* that bind with proteins on the surface of multiple myeloma cells and T cells, which activates T cells and kills tumor cells.
  *Antibody is a protein that helps protect the body against foreign matter, such as bacteria and viruses.
  In this study, researchers want to learn about effectiveness of Tal-pomalidomide (Tal-P) or Tal-Tec compared to elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd). One way to see how well a new treatment works is to measure the time it takes for the disease to come back or get worse. Participants will have an equal chance of receiving either Tal-P or Tal-Tec in addition to EPd or PVd treatment chosen by the study doctor. This is an open-label study, which means that the participant, caregiver, and the study doctor will know about the study drug received.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  23/EM/0251

• Date of REC Opinion

  7 Dec 2023

• REC opinion

  Further Information Favourable Opinion