Un ensayo de ventana de oportunidad para saber si linvoseltamab es seguro y bien tolerado, y qué tan bien funciona en participantes con mieloma múltiple recientemente diagnosticado que aún no han recibido tratamiento. (LINKER-MM4)
5 de noviembre de 2026 actualizado por: Regeneron Pharmaceuticals
Estudio de fase 1/2 de linvoseltamab (anticuerpo biespecífico anti-BCMA X anti-CD3) en pacientes con mieloma múltiple sintomático sin tratamiento previo
This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible).
The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM.
This study consists of 2 phases:
- In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2.
- In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug.
- In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM.
The study is looking at several research questions, including:
- What side effects may happen from taking linvoseltamab?
- What the right dosing regimen is for linvoseltamab?
- How many participants treated with linvoseltamab have improvement of their disease and for how long?
- The effects of linvoseltamab study treatment before and after transplant
- How much linvoseltamab is in the blood at different times?
- Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
148
Fase
- Fase 2
- 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.
Ubicaciones de estudio
-
-
-
Barcelona, España, 08036
- Hospital Clinic de Barcelona
-
Barcelona, España, 08908
- Institut Catala dOncologia (ICO Hospitalet)
-
Madrid, España, 28027
- Clinica Universidad de Navarra - Madrid
-
Madrid, España, 28006
- Universitary Hospital La Princesa
-
Salamanca, España, 37007
- Hospital Universitario de Salamanca
-
Valencia, España, 46026
- Hospital Universitari i Politecnic La Fe
-
-
Barcelona
-
Badalona, Barcelona, España, 08916
- Hospital Germans Trias i Pujol
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, España, 28223
- Hospital Universitario Quiron Salud Madrid
-
-
Navarre
-
Pamplona, Navarre, España, 31008
- Clinica Universidad de Navarra
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, España, 33011
- Hospital Universitario Central de Asturias
-
-
Valencia
-
Alicante, Valencia, España, 03010
- Hospital General Universitario Doctor Balmis Alicante
-
-
-
-
California
-
Los Angeles, California, Estados Unidos, 90095
- University of California Los Angeles (UCLA)
-
Orange, California, Estados Unidos, 92868
- UC Irvine Health
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80218
- Colorado Blood Cancer Institute/SCRI
-
-
Kentucky
-
Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
-
-
New Jersey
-
New Brunswick, New Jersey, Estados Unidos, 08901
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Mineola, New York, Estados Unidos, 11501
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
-
New York, New York, Estados Unidos, 10016
- Perlmutter Cancer Center
-
New York, New York, Estados Unidos, 10032
- Columbia University _ New York Presbyterian
-
Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28204
- Levine Cancer Institute
-
Durham, North Carolina, Estados Unidos, 27705
- Duke University Health System (DUHS)
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
-
-
-
-
-
Lille, Francia, 59000
- CHU De Lille
-
Montpellier, Francia, 342950
- Centre Hospitalier Universitaire (CHU) Montpellier
-
Paris, Francia, 75010
- Hopital Saint Louis
-
Paris, Francia, 75651
- University Hospitals Pitie Salpetriere - Charles Foix
-
-
Vienne
-
Poitiers, Vienne, Francia, 86021
- Centre Hospitalier Universitaire (CHU) de Poitiers
-
-
Île-de-France Region
-
Antony, Île-de-France Region, Francia, 92160
- Hopital Prive d'Antony
-
Paris, Île-de-France Region, Francia, 75015
- Hopital Necker
-
Villejuif, Île-de-France Region, Francia, 94800
- Gustave Roussy
-
-
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
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
- Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
- No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
- Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
- Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.
Key Exclusion Criteria:
- Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
- Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
- Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
- Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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: Phase 1 cohorts
Linvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve. |
Linvoseltamab will be administered by intravenous (IV) infusion
Otros nombres:
|
|
Experimental: Phase 2 - transplant ineligible cohort
Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol. |
Linvoseltamab will be administered by intravenous (IV) infusion
Otros nombres:
|
|
Experimental: Phase 2 - transplant eligible cohort
Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol |
Linvoseltamab will be administered by intravenous (IV) infusion
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Dose-Limiting Toxicities (DLTs)
Periodo de tiempo: End of the Observation period; up to day 28
|
Phase 1 |
End of the Observation period; up to day 28
|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of TEAEs
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of Adverse Events of Special Interest (AESIs)
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of AESIs
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria
Periodo de tiempo: Up to 5 years
|
Phase 2 |
Up to 5 years
|
|
Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy
Periodo de tiempo: Up to 5 years
|
Phase 2 Transplant-eligible cohort |
Up to 5 years
|
|
Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy
Periodo de tiempo: Up to 5 years
|
Phase 2 Transplant-eligible cohort |
Up to 5 years
|
|
Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II
Periodo de tiempo: Up to 5 years
|
Phase 2 Transplant-ineligible cohort |
Up to 5 years
|
|
Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II
Periodo de tiempo: Up to 5 years
|
Phase 2 Transplant ineligible cohort |
Up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concentrations of Linvoseltamab in serum
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 12 weeks
|
Phases 1 and 2 |
Post-Last Linvoseltamab Dose, up to 12 weeks
|
|
Concentrations of total soluble B-Cell Maturation Antigen (BCMA)
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 12 weeks
|
Phases 1 and 2 |
Post-Last Linvoseltamab Dose, up to 12 weeks
|
|
Incidence of Anti-Drug Antibodies (ADAs) to Linvoseltamab
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 30 days
|
Phases 1 and 2 |
Post-Last Linvoseltamab Dose, up to 30 days
|
|
Magnitude of ADAs to Linvoseltamab
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 30 days
|
Phases 1 and 2 |
Post-Last Linvoseltamab Dose, up to 30 days
|
|
Objective Response Rate (ORR) measured using the IMWG criteria
Periodo de tiempo: Up to 5 years
|
Phase 1 |
Up to 5 years
|
|
Duration Of Response (DOR) measured using the IMWG criteria
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Progression-Free Survival (PFS) measured using the IMWG criteria
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Proportion of participants achieving MRD-negative status (at 10^-5) in participants with NDMM measured using the IMWG criteria
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of TEAEs
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of TEAEs
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of AESIs
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of AESIs
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Periodo de tiempo: Up to 5 years
|
Phase 2 |
Up to 5 years
|
|
MRD-negative status of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
PFS of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Time To Response (TTR) as measured using the IMWG criteria
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
ORR by risk levels
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
MRD-negative status by risk levels
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
DOR by risk levels
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
TTR by risk levels
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
PFS by risk levels
Periodo de tiempo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of MRD-negative status
Periodo de tiempo: Up to 5 years
|
Phase 2 |
Up to 5 years
|
|
Cluster of Differentiation 34+ (CD34+) stem cell yield
Periodo de tiempo: At cycle 4 of induction (each cycle is 28 days long)
|
Phase 2 Transplant-eligible cohort |
At cycle 4 of induction (each cycle is 28 days long)
|
|
Time to neutrophil engraftment
Periodo de tiempo: Up to 100 days post-transplant
|
Phase 2 Transplant-eligible cohort |
Up to 100 days post-transplant
|
|
Time to platelet engraftment
Periodo de tiempo: Up to 100 days post-transplant
|
Phase 2 Transplant-eligible cohort |
Up to 100 days post-transplant
|
|
PFS after ASCT followed by 3 cycles of linvoseltamab
Periodo de tiempo: Up to 5 years
|
Phase 2 Transplant-eligible cohort |
Up to 5 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trial Management, Regeneron Pharmaceuticals
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)
19 de diciembre de 2023
Finalización primaria (Estimado)
2 de noviembre de 2035
Finalización del estudio (Estimado)
2 de noviembre de 2035
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2023
Primero enviado que cumplió con los criterios de control de calidad
12 de abril de 2023
Publicado por primera vez (Actual)
25 de abril de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de noviembre de 2026
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- 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
- Enfermedades hemic y linfáticas
- Mieloma múltiple
Otros números de identificación del estudio
- R5458-ONC-2158
- 2022-500800-24-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Marco de tiempo para compartir IPD
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
Criterios de acceso compartido de IPD
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
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
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. .