Un estudio de JNJ-79635322 en participantes con mieloma múltiple en recaída o refractario
Estudio de fase 1, primero en humanos, de aumento de dosis de JNJ-79635322, un anticuerpo triespecífico, en participantes con mieloma múltiple en recaída o refractario
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Edegem, Bélgica, 2650
- Reclutamiento
- UZ Antwerpen
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Ghent, Bélgica, 9000
- Reclutamiento
- UZ Gent
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Liège, Bélgica, 4000
- Reclutamiento
- CHU de Liege
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Badalona, España, 08916
- Reclutamiento
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, España, 08036
- Reclutamiento
- Hosp Clinic de Barcelona
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Madrid, España, 28040
- Reclutamiento
- Hosp Univ Fund Jimenez Diaz
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Pamplona, España, 31008
- Reclutamiento
- Clinica Univ. de Navarra
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Salamanca, España, 37007
- Reclutamiento
- Hosp Clinico Univ de Salamanca
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California
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Duarte, California, Estados Unidos, 91010
- Reclutamiento
- City of Hope
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Irvine, California, Estados Unidos, 92618
- Reclutamiento
- City of Hope Orange County Lennar Foundation Cancer Center
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San Francisco, California, Estados Unidos, 94143
- Reclutamiento
- University of California San Francisco
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Reclutamiento
- Colorado Blood Cancer Institute
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New York
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New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center
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New York, New York, Estados Unidos, 10029
- Reclutamiento
- Icahn School of Medicine at Mt. Sinai
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28001
- Reclutamiento
- Levine Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- MD Anderson Cancer Center
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Nantes, Francia, 44093
- Reclutamiento
- CHU Nantes
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Pierre-Bénite, Francia, 69495
- Reclutamiento
- CHU Lyon Sud
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Rennes, Francia, 35000
- Terminado
- Chu Rennes Hopital Pontchaillou
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Toulouse, Francia, 31100
- Reclutamiento
- Institut Claudius Regaud
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Shibuya City, Japón, 150-8935
- Activo, no reclutando
- Japanese Red Cross Medical Center
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Suita-shi, Japón, 565-0871
- Activo, no reclutando
- Osaka University Hospital
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Tokyo, Japón, 135-8550
- Terminado
- The Cancer Institute Hospital of JFCR
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Amsterdam, Países Bajos, 1081 HV
- Reclutamiento
- VUMC Amsterdam
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Groningen, Países Bajos, 9713 GZ
- Reclutamiento
- Universitair Medisch Centrum Groningen
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Utrecht, Países Bajos, 3584 CX
- Reclutamiento
- UMC Utrecht
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London, Reino Unido, W1T 7HA
- Reclutamiento
- University College Hospital
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Sutton, Reino Unido, SM2 5PT
- Reclutamiento
- Royal Marsden 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:
For participants with relapsed or refractory multiple myeloma:
- Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
- Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)
For participants with previously treated AL amyloidosis:
- Initial histopathological diagnosis of amyloidosis
- Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
- Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) >=50 mg/L or difference between involved and uninvolved free light chains (dFLC) >=50 mg/L, or serum m-protein >= 0.5 g/dL
- One or more organs impacted by systemic AL amyloidosis
- Left ventricular ejection fraction (LVEF) >=45%
Exclusion Criteria:
For participants with relapsed or refractory multiple myeloma:
- 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
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])
- 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
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
- The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled 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)
- Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration
For participants with previously treated AL amyloidosis:
- CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
- Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
- Pulmonary compromise requiring supplemental oxygen use
- Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
- Previous or current diagnosis of symptomatic multiple myeloma
- Macroglossia that impairs swallowing difficulty
- Received a cumulative dose of corticosteroids equivalent to > 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
- 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
- Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part 1: Dose Escalation
Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
JNJ-79635322 will be administered as SC injection. |
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Experimental: Part 2: Dose Expansion
Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1. |
JNJ-79635322 will be administered as SC injection. |
¿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 2 years 5 months
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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 2 years 5 months
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Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
Periodo de tiempo: Up to 2 years 5 months
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An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. |
Up to 2 years 5 months
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Part 2: Number of Participants with Abnormalities in Laboratory Values
Periodo de tiempo: Up to 2 Years 5 months
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Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported. |
Up to 2 Years 5 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Concentration of JNJ-79635322
Periodo de tiempo: Up to 2 Years 5 months
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Serum samples will be analyzed to determine concentrations of JNJ-79635322. |
Up to 2 Years 5 months
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Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322
Periodo de tiempo: Up to 2 Years 5 months
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Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported. |
Up to 2 Years 5 months
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Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria
Periodo de tiempo: Up to 2 Years 5 months
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Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. |
Up to 2 Years 5 months
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Time to Response (TTR) as Defined by IMWG 2016 Response Criteria
Periodo de tiempo: Up to 2 Years 5 months
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TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria. |
Up to 2 Years 5 months
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Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria
Periodo de tiempo: Up to 2 Years 5 months
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DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first. |
Up to 2 Years 5 months
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Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria
Periodo de tiempo: Up to 2 Years 5 months
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TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by International Amyloidosis Consensus Criteria. |
Up to 2 Years 5 months
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Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria
Periodo de tiempo: Up to 2 Years 5 months
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DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first. |
Up to 2 Years 5 months
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Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria
Periodo de tiempo: Up to 2 Years 5 months
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Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria. |
Up to 2 Years 5 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicaciones y enlaces útiles
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 metabólicas
- 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
- Deficiencias de proteostasis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Enfermedades hemic y linfáticas
- Reaparición
- Mieloma múltiple
- Amilosis
Otros números de identificación del estudio
- CR109234
- 2022-001465-12 (Número EudraCT)
- 79635322MMY1001 (Otro identificador: Janssen Research & Development, LLC)
- 2023-503679-12-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
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. .