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.
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
Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2
Must sign an informed consent form (ICF)
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 of trial intervention 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
Parallel
Ramantamig
DrugRamantamig will be administered subcutaneously.
Daratumumab
DrugDaratumumab will be administered subcutaneously.
Lenalidomide
DrugLenalidomide will be administered orally.
Bortezomib
DrugBortezomib will be administered subcutaneously or intravenously.
Dexamethasone
DrugDexamethasone will be administered orally or intravenously.
Progression-Free Survival (PFS)
PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first.
Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
12-month MRD-negative CR rate is defined as participants who achieve MRD-negative status at 12 months (+/-3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, participant must achieve CR or better any time from randomization up to and including 12+3 months prior to PD or subsequent antimyeloma therapy, according to international myeloma working group (IMWG) criteria.
Overall Survival (OS)
OS is defined as time from treatment assignment (that is, randomization in the trial) to date of death due to any cause.
Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR
24-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS for at least 24 months without any examination showing MRD positive status or PD in between.
Percentage of Participants with Very Good Partial Response (VGPR) or Better
Percentage of participants achieving VGPR, CR, or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.
Percentage of Participants with CR or Better
Percentage of participants achieving CR, or sCR prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.
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