Un estudio de JNJ-87562761 en participantes con mieloma múltiple en recaída o refractario
Un estudio de fase 1, primero en humanos, de etiqueta abierta y de aumento de dosis de JNJ-87562761 en mieloma múltiple en recaída o refractario
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
- Jewish General Hospital
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Seoul, Corea del Sur, 137 701
- The Catholic University of Korea Seoul St Marys Hospital
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Badalona, España, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, España, 08036
- Hosp Clinic de Barcelona
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Madrid, España, 28040
- Hosp Univ Fund Jimenez Diaz
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Pamplona, España, 31008
- Clinica Univ. de Navarra
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Salamanca, España, 37007
- Hosp Clinico Univ de Salamanca
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Kaohsiung City, Taiwán, 833
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwán, 404
- China Medical University Hospital
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Tainan, Taiwán, 70403
- National Cheng Kung University Hospital
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Taipei, Taiwán, 100225
- National Taiwan University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serum monoclonal paraprotein (M-protein) level greater than (>)0.5 grams per deciliter (g/dL); or (b) Urine M-protein level >200 milligrams per 24 hours (mg/24 hours); or (c) Light chain multiple myeloma: serum immunoglobulin free light chain (FLC) >10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLC ratio
- Must have had prior therapy including a proteasome inhibitor, immunomodulatory agent and anti-CD38 therapy
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Have an estimated glomerular filtration rate (eGFR), of > 30 millilitres (mL)/min/1.73 meter square (m^2) computed per 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation
- While on study treatment and for 6 months after the last dose of study treatment, a participant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; (c) Wear an external condom
Exclusion Criteria:
- Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or immunoglobulin light chain amyloidosis
- Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to less than or equal to (<=) Grade 1 (except alopecia, tissue post-RT fibrosis, or Grade < 3 peripheral neuropathy)
- Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy in the specified time frame prior to the first dose of study treatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, or treatment with an investigational drug or an invasive investigational medical device or conventional chemotherapy within 21 days, gene-modified adoptive cell therapy or treatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor [PI] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agent therapy within 7 days)
- Following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection (participants with a detectable viral load or low CD4 count), active hepatitis B or C infection, active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment, serious uncontrolled ongoing viral or bacterial or systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera [etc.])
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: JNJ-87562761
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. |
JNJ-87562761 will be administered. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Periodo de tiempo: up to approximately 3 years
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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
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Part 1 and 2: Number of Participants with Adverse Events (AEs)
Periodo de tiempo: up to approximately 3 years
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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
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Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values
Periodo de tiempo: up to approximately 3 years
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Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported. |
up to approximately 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Concentration of JNJ-87562761
Periodo de tiempo: up to approximately 3 years
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Serum samples will be analyzed to determine concentrations of JNJ-87562761. |
up to approximately 3 years
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Pharmacokinetic (PK) Parameters of JNJ-87562761
Periodo de tiempo: up to approximately 3 years
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PK parameters for JNJ-87562761 will be evaluated. |
up to approximately 3 years
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Number of Participants with Presence of Anti-JNJ-87562761 Antibodies
Periodo de tiempo: up to approximately 3 years
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Number of participants with presence of anti-JNJ-87562761 antibodies will be reported. |
up to approximately 3 years
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Percentage of Participants with Response
Periodo de tiempo: up to approximately 3 years
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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
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Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better
Periodo de tiempo: up to approximately 3 years
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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
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Percentage of Participants Who Achieve Complete Response (CR) or Better
Periodo de tiempo: up to approximately 3 years
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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
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Percentage of Participants Who Achieve Stringent Complete Response (sCR)
Periodo de tiempo: up to approximately 3 years
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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
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Duration of Response (DOR)
Periodo de tiempo: up to approximately 3 years
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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
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Time to Response (TTR)
Periodo de tiempo: up to approximately 3 years
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Neoplasias
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Reaparición
- Mieloma múltiple
Otros números de identificación del estudio
- 87562761MMY1001
- 87562761MMY1001 (Otro identificador: Janssen Research & Development, LLC)
- 2024-513439-25-00 (Identificador de registro: EUCT number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .