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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
Sponsor: Janssen Research & Development, LLC
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.
Official title: A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-09-14
Completion Date
2035-02-02
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Ramantamig
Ramantamig will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Lenalidomide
Lenalidomide will be administered orally.
Bortezomib
Bortezomib will be administered subcutaneously or intravenously.
Dexamethasone
Dexamethasone will be administered orally or intravenously.