رادار التجارب السريرية

Cohorts A and C: 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 2.9 years

Cohorts A and C: Duration of Response (DOR)

DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to PD, whichever occurs first.

Up to 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate

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

Up to 2.9 years

Cohorts A and C: Stringent Complete Response (sCR) Rate

sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.

Up to 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: Progression-free Survival (PFS)

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

Up to 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate

MRD-negative rate is defined as the proportion of participants who achieved MRD-negative status to a threshold of 10\^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy

Up to 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: 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 experience, 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 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values

Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.

Up to 2.9 years

Cohorts A and C: Serum Concentration of Teclistamab

Serum concentrations of teclistamab will be reported.

Up to 3 months

Cohorts A and C: Number of Participants with Teclistamab Antibodies

Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.

Up to 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: 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 2.9 years

Cohorts A and C: 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 (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).

Up to 2.9 years