The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
Teclistamab will be administered subcutaneously.
Kameda Medical Center
Chiba, Japan
Ogaki Municipal Hospital
Gifu, Japan
National Hospital Organization Mito Medical Center
Phase 1: Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Time frame: Up to 1 year and 5 months
Phase 1: Number of Participants with Serious Adverse Events (SAE)
A SAE is any untoward medical occurrence that at any dose: 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; is medically important.
Time frame: Up to 1 year and 5 months
Phase 1: Number of Participants with Dose Limiting Toxicity (DLT)
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Up to 28 days
Phase 2: Overall response rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Time frame: Up to 1 year and 5 months
Phase 1 and Phase 2: Serum Concentration of Teclistamab
Serum concentration of Teclistamab will be assessed.
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Higashiibaraki-gun, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Kurume University Hospital
Kurume, Japan
Kyoto Kuramaguchi Medical Center
Kyoto, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, Japan
Nagoya City University Hospital
Nagoya, Japan
Niigata Cancer Center Hospital
Niigata, Japan
...and 5 more locations
Time frame: Up to 1 year and 5 months
Phase 1: Systemic Cytokine Concentrations
Cytokines concentration will be measured for biomarker assessment.
Time frame: Up to 1 year and 5 months
Phase 1 and Phase 2: Number of Participants with Anti-teclistamab Antibodies
Number of participants with anti-teclistamab antibodies will be assessed.
Time frame: Up to 1 year and 5 months
Phase 1: Objective Response Rate
Objective response will be defined as partial response (PR) or better as defined by the 2016 IMWG response criteria in multiple myeloma (MM).
Time frame: Up to 1 year and 5 months
Phase 1 and Phase 2: Duration of Response (DOR)
DOR is defined as the duration 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 2016 IMWG criteria, or death.
Time frame: Up to 1 year and 5 months
Phase 1 and Phase 2: Time to Response (TTR)
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation that the participant has met all criteria for PR or better.
Time frame: Up to 1 year and 5 months
Phase 2: Very Good Partial Response (VGPR) or Better Response Rate (Stringent Complete Response [sCR]+ Complete Response [CR]+VGPR)
VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the 2016 IMWG response criteria.
Time frame: Up to 1 year and 5 months
Phase 2: Complete Response (CR) or Better Response Rate
CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Time frame: Up to 1 year and 5 months
Phase 2: Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
Time frame: Up to 1 year and 5 months
Phase 2: 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 2016 IMWG response criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 1 year and 5 months
Phase 2: 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. 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.
Time frame: Up to 1 year and 5 months
Phase 2: Minimal Residual Disease (MRD)-negative Rate
MRD-negative rate is defined as the percentage 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.
Time frame: Up to 1 year and 5 months
Phase 2: Number of Participants with AEs
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Time frame: Up to 1 year and 5 months
Phase 2: 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) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Time frame: Up to 1 year and 5 months
Phase 2: Number of Participants with SAEs
A SAE is any untoward medical occurrence that at any dose: 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; is medically important.
Time frame: Up to 1 year and 5 months
Phase 2: Number of Participants with SAEs by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Time frame: Up to 1 year and 5 months
Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values
Number of participants with abnormalities in clinical laboratory test values of hematology, serum chemistry, and coagulation will be reported.
Time frame: Up to 1 year and 5 months
Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Test Values by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Time frame: Up to 1 year and 5 months
Phase 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
Change from baseline in EORTC- QLQ-C30 score will be reported. 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), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and 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.
Time frame: Up to 1 year and 5 months
Phase 2: Change from Baseline in EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) Scale
Change from baseline in EQ-5D-5L scale will be reported. The EQ-5D-5L is a generic measure of health status. 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).
Time frame: Up to 1 year and 5 months
Phase 2: Change from Baseline in Patient Global Impression of Severity (PGIS) Scale
Change from baseline in PGIS scale will be reported. The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale (1: None, 2: Mild, 3: Moderate, 4: Severe, 5: Very Severe) at the time of completing the PRO measure. Higher score indicate greater severity.
Time frame: Up to 1 year and 5 months