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

NCT07665450

Phase 3 Not yet recruiting 1000 enrolled Janssen Research & Development, LLC
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

EvaluationDrugModalityDoseRoute
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

Indications