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| ID | Type | Description | Link |
|---|---|---|---|
| 87562761MMY1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2024-513439-25-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-87562761 | Experimental | Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-87562761 | Drug | JNJ-87562761 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) | DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. | up to approximately 3 years |
| Part 1 and 2: Number of Participants with Adverse Events (AEs) | Number of participants with AEs will be reported. 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 approximately 3 years |
| Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values | Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported. | up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-87562761 | Serum samples will be analyzed to determine concentrations of JNJ-87562761. | up to approximately 3 years |
| Pharmacokinetic (PK) Parameters of JNJ-87562761 | PK parameters for JNJ-87562761 will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada | ||
| Jewish General Hospital |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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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| up to approximately 3 years |
| Number of Participants with Presence of Anti-JNJ-87562761 Antibodies | Number of participants with presence of anti-JNJ-87562761 antibodies will be reported. | up to approximately 3 years |
| Percentage of Participants with Response | Overall response is defined as a best response of partial response (PR) or better as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. | up to approximately 3 years |
| Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better | VGPR or better response is defined as the percentage of participants who achieve a best response of VGPR or better as assessed by IMWG 2016 response criteria. | up to approximately 3 years |
| Percentage of Participants Who Achieve Complete Response (CR) or Better | CR or better response is defined as percentage of participants who achieve a best response of CR or better as assessed by IMWG 2016 response criteria. | up to approximately 3 years |
| Percentage of Participants Who Achieve Stringent Complete Response (sCR) | sCR is defined as the percentage of participants who achieve a best response of sCR as assessed by IMWG 2016 response criteria. | up to approximately 3 years |
| Duration of Response (DOR) | DOR is defined for participants who achieve a response of PR or better as the time from the first efficacy evaluation at which the participant met all criteria for a response of PR or better to the time of first documented evidence of progressive disease or death, assessed by IMWG 2016 response criteria. | up to approximately 3 years |
| Time to Response (TTR) | TTR is defined for participants who achieve a response of PR or better as the time from the first dose of study drug to the time of the first efficacy evaluation at which the participant met all criteria for a response of PR or better, assessed by IMWG 2016 response criteria. | up to approximately 3 years |
| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 137 701 | South Korea |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 100225 | Taiwan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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