drugset / Trial / NCT07665450
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \[WBCs\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.
Timeline
- Start
- 2026-09-14
- Primary completion
- 2030-09-04
- Completion
- 2035-02-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-79635322 | Unknown | — | Subcutaneous |
| Comparator | Bortezomib | Small molecule | — | Subcutaneous |
| Background | Daratumumab | Monoclonal antibody | — | Subcutaneous |
| Comparator | Dexamethasone | Small molecule | — | Oral |
| Comparator | Lenalidomide | Other / unclassified | — | Oral |