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

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive.

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 in between, and prior to PD or subsequent antimyeloma therapy (including ASCT).

VGPR or better is defined as participants who achieve VGPR, CR, or stringent complete response (sCR) prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention.

CR or better is defined as participants who achieve CR or sCR prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention.

Overall response rate is defined as percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention.

Overall MRD-negative CR is defined as 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.

12-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS, for at least 12 months without any examination showing MRD positive status in between, and prior to PD or subsequent antimyeloma therapy (including ASCT).

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 study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy will be considered treatment-related regardless of the start date of the event. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.

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 treatment.

Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.

The MySIm-Q is a disease-specific patient reported outcome (PRO) assessment with established content validity for participants with newly diagnosed multiple myeloma (NDMM). It is included to be complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. 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); 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 analogue scale (EQ-VAS). The 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). Higher scores indicate worse HRQoL.

Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact.

Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 scale scores will be reported. 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.

Time to worsening in HRQoL, symptoms and functioning using the EQ-5D-5L scale scores will be reported. The EQ-5D-5L descriptive system covers 5 dimensions of health each with 5 levels of severity with higher scores indicating worse HRQoL.

Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning using MySIm-Q scale score will be reported. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact.

Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning as assessed by EORTC-QLQ-C30 scale score will be reported. he item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning using EQ-5D-5L scale score will be reported. The EQ-5D-5L descriptive system covers 5 dimensions of health each with 5 levels of severity with higher scores indicating worse HRQoL.

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.