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A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to compare how well Ramantamig plus Daratumumab (ramantamig-D) works compared with a treatment that includes Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd), followed by high-dose therapy, autologous stem cell transplantation (using the participant's own stem cells), and maintenance treatment with Daratumumab and Lenalidomide (DR) in participants with newly diagnosed multiple myeloma (NDMM), a blood cancer affecting plasma cells, who are eligible for transplant.
Official title: A Phase 3 Randomized Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) and Daratumumab and Lenalidomide (DR) Maintenance (DVRd + High-dose Therapy [HDT] + ASCT + DR) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-12-14
Completion Date
2037-01-11
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Ramantamig
Ramantamig will be administered as subcutaneous (SC) injection.
Daratumumab
Daratumumab will be administered as SC injection.
Bortezomib
Bortezomib will be administered as SC injection.
Lenalidomide
Lenalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously (IV).
HDT+ASCT
HDT and ASCT will be performed as per standard of care.