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

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.

Trial Details

NCT ID
NCT07665450
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Ramantamig
  • Daratumumab
  • Lenalidomide
  • Bortezomib
  • Dexamethasone
Locations (sample)
  • Darlinghurst, Australia|-33.87939,151.21925
  • South Brisbane, Australia|-27.48034,153.02049
  • Brno, Czechia|49.19522,16.60796
  • Hradec Králové, Czechia|50.20923,15.83277
  • Ostrava, Czechia|49.83465,18.28204

Key Eligibility Criteria

  • Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria
  • Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. inelig…
  • Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2
  • Must sign an informed consent form (ICF)

For full eligibility, visit ClinicalTrials.gov.

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