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Case study: MonumenTAL-6

A study comparing the effectiveness of the drugs Tal-pomalidomide (Tal-P) or Tal-Tec when taken in combination with others to treat blood cancer.

Sponsor: Janssen-Cilag International NV

Cancer type: Relapsed or refractory multiple myeloma

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.

In this study, researchers want to learn about effectiveness of the drugs Tal-pomalidomide (Tal-P) or Tal-Tec when taken in combination with others including 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.

The trial is also enabling trial patients to access Talquetamab and teclistamab. These are drugs that use modified antibodies to bind with proteins on the surface of multiple myeloma cells and T cells, which activates T cells and kills tumour cells.

“Myeloma is an expensive disease to treat but patients who become part of the trial will have their standard treatment and the trial drugs funded by Janssen Pharmaceuticals, meaning a significant saving to the NHS.

Although many new drugs have been approved to treat myeloma recently which can extend patient survival, Talquetamab is not available outside of trials and neither is the standard of care treatment (Elotuzumab-Pom-Dex). Therefore all patients recruited to this trial will benefit from treatment they could not access via the NHS and many will live longer as a result.”

Ceri Bygrave, Consultant Haematologist and Clinical Lead for Myeloma, University Hospital Wales

Cardiff Cancer Research Hub haematology expert Dr Ceri Bygrave wearing black jacket and cream shirt

“This trial demonstrates all the benefits of the Cardiff Cancer Research Hub. The collaboration has seen us upskilling the workforce, with research nursing working at both Velindre Cancer Centre and University Hospital Wales (UHW).

Janssen Pharmaceutical have been very supportive, providing joint training for Hub and UHW staff so we all have the skills and information needed to run this trial.”

Claire Lang, Senior Research Nurse Manager, Cardiff Cancer Research Hub

Full Study 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