MajesTEC-10
Research type
Research Study
Full title
A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants with Relapsed/Refractory Multiple Myeloma
IRAS ID
1009491
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2023-508426-10
ISRCTN Number
ISRCTN46766641
Research summary
Multiple myeloma (MM) is a blood cancer that forms in a type of white blood cells (WBCs) called plasma cells. Drugs that activate T-cells (type of WBCs) to attack cancer cells may be an effective way to destroy them. Teclistamab binds to a protein called cluster of differentiation 3 (CD3) receptor, which is found on T-cells. It also binds to a protein called B-cell maturation antigen (BCMA), which is found on myeloma cells and some B-cells (another type of WBCs). This activates the T-cells and leads to killing of myeloma cells. In this study, the researchers want to learn more about how teclistamab made from the current commercial manufacturing process (pre-change) gets absorbed, distributed in the body, and excreted (pharmacokinetics) compared to the teclistamab made from new manufacturing process (post-change).
Who can participate?
Study will include male and female participants 18 years or older, diagnosed with relapsed (it comes back after treatment) or refractory (does not respond to treatment) multiple myeloma.
What does the study involve?
At the start of the study, study doctors will confirm if the participants can take part in the study. They will divide participants into either of the 2 treatment groups in a random way to receive the treatment in 28-day cycles: Arm A (Pre-change teclistamab as an injection under the skin) and Arm B (Post-change teclistamab as an injection under the skin).
Participants will be followed-up for their overall health throughout the study. During the study, some tests such as blood and urine tests, imaging scans, and bone marrow testing will be performed. Blood samples will be taken at multiple timepoints to see how the body responds to treatment. Disease status will be checked based on International Myeloma Working Group (IMWG) criteria for multiple myeloma. Side effects will be recorded until study ends (Up to approximately 3 years).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0076
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion