The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Teclistamab will be administered subcutaneously.
Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab
Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).
Time frame: Cycle 1 (28 days cycle): Predose to Day 7 postdose
Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose
AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).
Time frame: Cycle 1 (28 days cycle): Predose to Day 7 postdose
Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1
Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.
Time frame: Cycle 3 (28 days cycle): Day 1
Number of Participants with Anti-drug Antibodies (ADAs)
Number of participants with ADAs to teclistamab will be reported.
Time frame: Up to approximately 3 years
Percentage of Participants With Complete Response (CR) or Better Response
Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Time frame: Up to approximately 3 years
Number of Participants with Adverse Events (AEs) by Severity
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
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Time frame: Up to approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
Time frame: Up to approximately 3 years
Number of Participants with Abnormal Laboratory Results
Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.
Time frame: Up to approximately 3 years
Percentage of Participants With Overall Response (Partial Response [PR] or Better)
Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria.
Time frame: Up to approximately 3 years
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Time frame: Up to approximately 3 years