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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or iii. deferral of high-dose chemotherapy with ASCT as initial treatment

Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2

Must sign an informed consent form (ICF)

Disqualifiers

Myeloma Frailty Score of greater than or equal to (>=) 2 with the exception of participants who have a score of 2 based on age alone

Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients

Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial

Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM

Trial design

Treatments tested in this trial

  • Ramantamig
  • Daratumumab
  • Lenalidomide
  • Bortezomib
  • Dexamethasone

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Locations

This trial has no locations