A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04773522|
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : September 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Talquetamab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of JNJ-64407564, a Humanized GPRC5D * CD3 Bispecific Antibody in Japanese Subjects With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||May 20, 2021|
|Estimated Primary Completion Date :||September 16, 2022|
|Estimated Study Completion Date :||January 9, 2023|
Participants will receive talquetamab injection subcutaneously (SC) in 3 cohorts: Cohort 1 and Cohort 2 as 2 step-up doses and Cohort 3 as 3 step-up doses followed by a treatment dose.
Talquetamab will be administered subcutaneously.
Other Name: JNJ-64407564
- Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 1.5 years ]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.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 1.5 years ]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.
- Cohorts 1 and 2: Number of Participants With Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]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.
- Cohort 3: Number of Participants With DLT [ Time Frame: Up to 38 days ]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.
- Serum Concentrations of JNJ-64407564 [ Time Frame: Up to 1.5 years ]Serum concentrations of JNJ-64407564 will be assessed.
- Systemic Cytokine Concentrations [ Time Frame: Up to 1.5 years ]Cytokine concentrations such as concentration of interleukin (IL)-6, Interferon (IFN)-gamma, IL-10 and IL-2 receptors will be measured for biomarker assessment.
- Number of Participants With Anti-Talquetamab Antibodies [ Time Frame: Up to 1.5 years ]Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment.
- Number of Participants With Objective Response [ Time Frame: Up to 1.5 years ]Objective response is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
- Duration of Response (DOR) [ Time Frame: Up to 1.5 years ]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 to Response (TTR) [ Time Frame: Up to 1.5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773522
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Shonan Kamakura General Hospital||Recruiting|
|Kamakura-shi, Japan, 247-8533|
|National Cancer Center Hospital East||Recruiting|
|Kashiwa, Japan, 277-8577|
|Nagoya City University Hospital||Recruiting|
|Nagoya, Japan, 467-8602|
|National Hospital Organization Okayama Medical Center||Recruiting|
|Okayama, Japan, 701-1192|
|Japanese Red Cross Medical Center||Recruiting|
|Shibuya, Japan, 150-8935|
|Iwate Medical University Hospital||Recruiting|
|Shiwa-gun, Japan, 028-3695|
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|