The purpose of this study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D) identified in NCT03399799 study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Talquetamab will be administered subcutaneously.
Shonan Kamakura General Hospital
Kamakura-shi, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Nagoya City University Hospital
Nagoya, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Number of Participants With Adverse Events (AEs)
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.
Time frame: Up to 1.5 years
Number of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 1.5 years
Cohorts 1 and 2: Number of Participants With Dose-Limiting Toxicity (DLT)
Number of participants with DLT will be reported. 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
Cohort 3: Number of Participants With DLT
Number of participants with DLT will be reported. 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 38 days
Serum Concentrations of JNJ-64407564
Serum concentrations of JNJ-64407564 will be assessed.
Time frame: Up to 1.5 years
Systemic Cytokine Concentrations
Cytokine concentrations such as concentration of interleukin (IL)-6, Interferon (IFN)-gamma, IL-10 and IL-2 receptors will be measured for biomarker assessment.
Time frame: Up to 1.5 years
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Japanese Red Cross Medical Center
Shibuya City, Japan
Iwate Medical University Hospital
Shiwa-gun, Japan
Number of Participants With Anti-Talquetamab Antibodies
Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment.
Time frame: Up to 1.5 years
Number of Participants With Objective Response
Objective response is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Time frame: Up to 1.5 years
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 IMWG criteria, or death.
Time frame: Up to 1.5 years
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 1.5 years