MajesTEC-4
Research type
Research Study
Full title
Phase 3 Study of Teclistamab in Combination with Lenalidomide versus Lenalidomide Alone in Participants with Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
IRAS ID
1004739
Contact name
Prof. Pieter Sonneveld
Contact email
Sponsor organisation
European Myeloma Network (EMN)
Eudract number
2021-002531-27
Clinicaltrials.gov Identifier
Research summary
In this study we aim to further improve the treatment of Multiple Myeloma. Multiple Myeloma is caused by a growth of abnormal cells (plasma cells) in the bone marrow.
We mainly want to see how well adding Teclistamab to the standard maintenance treatment of Lenalidomide works compared to the standard treatment with Lenalidomide alone. The maintenance treatment follows autologous stem cell transplantation. Teclistamab is an antibody that can bind to malignant Multiple Myeloma cells and kill them.
We plan to run the study at several locations in different countries. We intended to include around 1020 patients.
European Myeloma Network (EMN) is organizing this study, and Jansen will fund it. The study will last 10 years (2 years treatment and 8 years follow up).
We designed this study as prospective, that is, we will treat patients and continually gather data, as opposed to analyzing data from the past. This is a randomized controlled study, which means that we will assign patients based on chance to one of the two treatment groups. This is also an open-label study, where both patients and investigators will be aware of which treatment is being given.
We will invite the patients to have a number of examinations such as bone marrow and blood tests. Depending on the treatment group, they will take either Lenalidomide, or Teclistamab together with Lenalidomide. In this study, we do not permit patients who, for example, have received prior BCMA-directed therapy, radiotherapy with-in 14 days prior to this study, have history of allogeneic stem cell transplantation or have myelodysplastic syndrome.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0118
Date of REC Opinion
10 Jun 2022
REC opinion
Further Information Favourable Opinion