Clinical Trial Radar

Overall Response Rate (ORR)

ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.

Up to 2 years and 10 months

Duration of Response (DOR)

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.

Up to 2 years and 10 months

Very Good Partial Response (VGPR) or Better Rate

VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

Up to 2 years and 10 months

Complete Response (CR) or Better Rate

CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.

Up to 2 years and 10 months

Stringent Complete Response (sCR) Rate

sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.

Up to 2 years and 10 months

Time to Response (TTR)

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.

Up to 2 years and 10 months

Progression-Free Survival (PFS)

PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.

Up to 2 years and 10 months

Overall Survival (OS)

OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

Up to 2 years and 10 months

Minimal Residual Disease (MRD) Negative Rate

MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data.

Up to 2 years and 10 months

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Up to 2 years and 10 months

Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Up to 2 years and 10 months

Number of Participants with AEs by Severity

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

Up to 2 years and 10 months

Number of Participants with Abnormalities in Clinical Laboratory Values

Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.

Up to 2 years and 10 months

Serum Concentration of Talquetamab

Serum samples will be analyzed to determine concentrations of talquetamab.

Up to 2 years and 10 months

Number of Participants with Talquetamab Antibodies

Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.

Up to 2 years and 10 months

Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)

The EORTC- QLQ-Core-30 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 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. 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.

Baseline up to 2 years and 10 months

Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)

The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.

Baseline up to 2 years and 10 months

Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)

The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).

Baseline up to 2 years and 10 months

Overall Response Rate (ORR) in Participants with High-risk Molecular Features

ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.

Up to 2 years and 10 months