Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Measured from the date of from randomization to the date the subject's death.

Minimal Residual Disease (MRD) negative as determined by NGF at 10^-5 sensitivity level per International Myeloma Working Group (IMWG) criteria.

Minimal Residual Disease (MRD) negative Complete Remission (CR) at the end of fixed treatment duration status as determined by NGF at 10^-5 sensitivity level and who also achieve CR or better per International Myeloma Working Group (IMWG) criteria.

Sustained MRD-negative CR is defined as patients with CR or better who sustain MRD-negative status, as determined NGF at 10^-5.

To evaluate the proportion of IMWG best response achieved by a patient during the study. Subject will be classified as Not Evaluable (NE) if they will not have any evaluable response assessment.

Time from the date of randomization to the date of first documentation of a confirmed response (partial response) as per IMWG response criteria, for patients who have PR or better as their best response.

Time from the date of randomization to the date of first best response as per IMWG response criteria.

Time from the date of randomization to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause or treatment discontinuation due to toxicity, whichever occurs first.

Time from the randomization date to the date of event, which is defined as death from any cause or progression disease on the next line of therapy, whichever occurs first.

Time from the randomization date to the date of event, which is defined as the start of the next line of therapy or death from any cause, whichever occurs first.

Incidence and severity of Adverse Events during initial therapy, Treatment-Free-Interval (TFI) and after restarting therapy.

Discontinuation rate and cause due to treatment related toxicity during initial therapy and after restarting therapy, including overall discontinuation rate, discontinuation rate of daratumumab, teclistamab and talquetamab.

The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items.

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 EORTC-QLQ-MY20 is a specialised tool designed to assess the quality of life in myeloma patients.

Scores are linearly transformed to a 0-100 scale, where higher scores on the symptom scales indicate worse outcomes.

The ADL questionnaire assesses functional status by measuring independence in six daily activities.

The ADL scale is scored from 0 to 8, where higher scores indicate greater independence with daily activities.

The IADL assesses instrumental activities of daily living, including telephone use, laundry, shopping, food preparation, and mode of transportation.

The IADL scale is scored from 0 to 8, with higher scores indicating greater independence.

The STTA scale assesses the taste acuity during treatment. The STTA scale is scored from 0 to 4, where 4 indicates almost complete loss of taste acuity.

The GDS scale assesses the depressive symptoms in frail elderly patients. The GDS scale is scored from 0 to 15. Score 1 point for each bolded answer. A score of 5 or more suggests depression.

The MNA is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition.

The MNA scale is scored from 1 to 30. A higher score represents good nutrition, a score less then 17 represents malnutrition.

The MMSE is an 11-question tool to assess mental status, testing five cognitive areas.

The MMSE scale is scored from 1 to 30. A higher score represents good mental state.

The GAH scale predicts treatment tolerability in older patients diagnosed with hematological malignancies.

The 30-item GAH scale was designed through a multi-step process to cover 8 relevant dimensions. Higher scores indicate a more frail or vulnerable patient.