A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
Summary
The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.
Timeline
- Start
- 2024-08-20
- Primary completion
- 2030-09-02
- Completion
- 2030-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Talquetamab | Monoclonal antibody | — | Subcutaneous |
| Subject | Teclistamab | Monoclonal antibody | — | Subcutaneous |
| Background | Bortezomib | Small molecule | — | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Daratumumab | Monoclonal antibody | — | Subcutaneous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Lenalidomide | Other / unclassified | — | Oral |
| Background | ciltacabtagene autoleucel | Cell therapy | — | Intravenous |