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A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma

24 de septiembre de 2026 actualizado por: Janssen Research & Development, LLC

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or in Combination With Pomalidomide for Multiple Myeloma

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

276

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Australia
      • Clayton, Australia, 3168
        • Reclutamiento
        • Monash Medical Centre
      • Fitzroy, Australia, 3065
        • Reclutamiento
        • St Vincents Hospital Melbourne
      • Melbourne, Australia, 3000
        • Reclutamiento
        • Peter MacCallum Cancer Centre
      • Waratah, Australia, 2298
        • Reclutamiento
        • Calvary Mater Newcastle Hospital
      • Wollongong, Australia, 2500
        • Reclutamiento
        • Wollongong Hospital
  • España
      • Barcelona, España, 08036
        • Reclutamiento
        • Hosp. Clinic de Barcelona
      • Salamanca, España, 37007
        • Reclutamiento
        • Hosp Clinico Univ de Salamanca
  • Estados Unidos
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
        • Reclutamiento
        • Colorado Blood Cancer Institute
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Winship Cancer Institute Emory University
  • Israel
      • Haifa, Israel, 3436212
        • Reclutamiento
        • Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Reclutamiento
        • Hadassah Medical Center
      • Ramat Gan, Israel, 52621
        • Reclutamiento
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Reclutamiento
        • Tel Aviv Sourasky Medical Center
  • Países Bajos
      • Amsterdam, Países Bajos, 1081 HV
        • Reclutamiento
        • VU Medisch Centrum
      • Groningen, Países Bajos, 9713 GZ
        • Reclutamiento
        • Universitair Medisch Centrum Groningen
      • Utrecht, Países Bajos, 3584 CX
        • Reclutamiento
        • UMC Utrecht

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria for newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R/R MM):

  • Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimens A1 and A3: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimens A2 and A4: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): Have received greater than or equal to (>=) 1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory OR >=2 prior lines of therapy, including a PI and lenalidomide; Treatment Regimens C, D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments
  • Have a weight >=40 kilograms
  • Must have an Eastern Cooperative Oncology Group status of 0 or 2
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level >= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level >=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 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 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-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated

Inclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis

  • Have a histopathological diagnosis of amyloidosis
  • Have an ECOG performance status of 0 to 1

Inclusion criteria for High-risk smoldering multiple myeloma (SMM)

  • Have a diagnosis of SMM (per IMWG criteria) for less than or equal to (<=) 5 years with measurable disease at the time of enrollment as defined in the protocol
  • Have an ECOG performance status of 0 to 1

Exclusion Criteria for NDMM and R/R MM:

  • Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor [CAR] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimens A, C, D and E only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
  • Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant <=12 weeks before the first dose of study treatment
  • Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy grade <=3)
  • Prior treatment with CD3-redirecting therapy

Exclusion Criteria for ND AL Amyloidosis

  • Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >=60 percent (%) plasma cells in the bone marrow, or hypercalcemia
  • Macroglossia that impairs swallowing difficulty
  • Prior therapy for AL amyloidosis or multiple myeloma

Exclusion Criteria for High-risk SMM

  • Multiple myeloma, requiring treatment
  • Primary systemic AL (immunoglobulin light chain) amyloidosis

Exclusion criteria for all participants:

  • Any serious underlying medical conditions, such as: Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment; active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment; cardiovascular dysfunction; 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
  • Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Treatment Regimen A and C: JNJ-79635322+Daratumumab

Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D[s]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Experimental: Treatment Regimen B: JNJ-79635322+Pomalidomide

Participants who have received greater than or equal to (>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or >=2 prior lines of therapy, including a PI and lenalidomide will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Pomalidomide

Pomalidomide will be administered orally.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Experimental: Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination

Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Lenalidomide

Lenalidomide will be administered orally.

Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Experimental: Treatment Regimen F: JNJ-79635322 + Daratumumab

Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.
Experimental: Treatment Regimen G: JNJ-79635322 + Daratumumab

Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.
Droga: Daratumumab

Daratumumab will be administered subcutaneously.

Droga: JNJ-79635322

JNJ-79635322 will be administered subcutaneously.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Periodo de tiempo: Up to 28 days

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
Number of Participants with Adverse Events (AEs) by Severity
Periodo de tiempo: Up to 3 Years and 3 months

An AE 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 3 Years and 3 months
Number of Participants with Clinically Significant Laboratory Abnormalities
Periodo de tiempo: Up to 3 Years and 3 months

Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
Up to 3 Years and 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Overall Response Rate
Periodo de tiempo: Up to 3 Years and 3 months

Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate
Periodo de tiempo: Up to 3 Years and 3 months

VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With CR or Better Response Rate
Periodo de tiempo: Up to 3 Years and 3 months

CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Percentage of Participants With sCR or Better Response Rate
Periodo de tiempo: Up to 3 Years and 3 months

sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria.
Up to 3 Years and 3 months
Duration of Response (DOR)
Periodo de tiempo: Up to 3 Years and 3 months

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), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM.
Up to 3 Years and 3 months
Time to Response (TTR)
Periodo de tiempo: Up to 3 Years and 3 months

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Up to 3 Years and 3 months
Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria
Periodo de tiempo: Up to 3 Years and 3 months

Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported.
Up to 3 Years and 3 months
DOR as Defined by International Amyloidosis Consensus Criteria
Periodo de tiempo: Up to 3 Years and 3 months

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), as per International amyloidosis consensus criteria, or death due to progression, whichever occurs first in participants with ND AL amyloidosis.
Up to 3 Years and 3 months
TTR as Defined by International Amyloidosis Consensus Criteria
Periodo de tiempo: Up to 3 Years and 3 months

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant with ND AL amyloidosis has met all criteria for PR or better as defined by International amyloidosis consensus criteria.
Up to 3 Years and 3 months
Serum Concentration of JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

AUCinf for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

AUC(0-t) for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

AUCtau for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

Cmax for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Half Life (T1/2) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

T1/2 for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

Tmax for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

CL/F for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

Vss/F for JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
Periodo de tiempo: Up to 3 Years and 3 months

Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.
Up to 3 Years and 3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de diciembre de 2024

Finalización primaria (Estimado)

2 de enero de 2029

Finalización del estudio (Estimado)

29 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

23 de diciembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

9 de enero de 2025

Publicado por primera vez (Actual)

10 de enero de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 79635322MMY1002
  • 2024-515316-44-00 (Identificador de registro: EUCT number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

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. .

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