drugset / Trial / NCT03984097
A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.
Timeline
- Start
- 2019-07-29
- Primary completion
- 2026-03-25
- Completion
- 2026-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mezagitamab | Monoclonal antibody | — | Subcutaneous |
| Background | Bortezomib | Small molecule | — | Subcutaneous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Lenalidomide | Other / unclassified | — | Oral |
| Background | Pomalidomide | Other / unclassified | — | Oral |