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

PFS is defined as the time from treatment assignment (that is, randomization in the trial) to confirmed progression of disease (PD) or death, whichever occurs first.

12-month MRD-negative CR rate is defined as achieving MRD-negative status at the analysis time window of 12 months (+/-3 months), as determined by next-generation sequencing (NGS) with sensitivity of 10^-5, prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, CR or better must be achieved any time from randomization up to and including 12+3 months, according to international myeloma working group (IMWG) criteria.

OS is defined as time from treatment assignment (that is, randomization in the trial) to date of death due to any cause.

24-month sustained MRD-negative CR is defined as achieving confirmed CR or better while sustaining MRD-negative status for at least 24 months without any examination showing MRD positive status or PD in between.

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 achieving CR, or sCR prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.

Percentage of participants achieving PR or better prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.

Percentage of participants who achieve MRD-negative status, as determined by NGS at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better will be reported.

Percentage of participants with confirmed CR or better who sustain MRD-negative status, as determined by NGS, for at least 12 months without any examination showing MRD-positive status or PD in between will be reported.

PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.

An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention.

The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.

The EORTC QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

The EQ-5D-5L is a self-administered, generic health status measure, consisting of a descriptive system and a visual analog scale (EQ-VAS). The EQ-5D-5L descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), each with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems) with higher scores indicating worse HRQoL.

The PGI-S is a 2-item questionnaire that assesses severity of the participant's symptoms and impacts of their symptoms, respectively, on a 5-point verbal rating scale, at the time of completing the PRO measure. Score ranges from 1 (None) to 5 (Very Severe). Higher scores indicate greater severity.

The EORTC IL46 consists of a single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4 point scale where higher scores indicate more symptoms.

Percentage of participants with tolerability to ramantamig-D measured through PROs will be reported.