The study focuses on patients who have been newly diagnosed with Multiple Myeloma and are eligible for a type of stem cell transplantation. The experimental regimen combines a new injectable antibody called teclistamab with a standard backbone that includes the oral drug lenalidomide, the injectable chemotherapy bortezomib, the monoclonal antibody daratumumab, and the steroid dexamethasone. The backbone medicines are given in the usual doses, while the new antibody is given under the skin based on body weight.
The purpose of the trial is to see whether this combination can achieve a deeper level of disease clearance, measured as MRD negativity using highly sensitive NGS testing, compared with the standard backbone alone. Participants will receive several cycles of treatment to reduce tumor burden, followed by a high dose chemotherapy called high dose melphalan and an autologous transplant, where their own stem cells are returned after the chemotherapy. After the transplant, patients will enter a simpler, long‑term phase to keep the disease under control, and they will be checked regularly for up to two years to see how long the deep response lasts.
Germany 
