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| ID | Type | Description | Link |
|---|---|---|---|
| 64407564MMY1003 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talquetamab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talquetamab | Drug | Talquetamab will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to 38 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of JNJ-64407564 | Serum concentrations of JNJ-64407564 will be assessed. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shonan Kamakura General Hospital | Kamakura-shi | 247-8533 | Japan | |||
| National Cancer Center Hospital East |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000730985 | talquetamab |
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| Up to 1.5 years |
| Number of Participants With Anti-Talquetamab Antibodies | Number of participants with anti-talquetamab antibodies will be reported for immunogenicity assessment. | 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. | 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. | 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. | Up to 1.5 years |
| Kashiwa |
| 277 8577 |
| Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | 701-1192 | Japan |
| Japanese Red Cross Medical Center | Shibuya City | 150-8935 | Japan |
| Iwate Medical University Hospital | Shiwa-gun | 028-3695 | Japan |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |