Uma janela de julgamento de oportunidade para saber se o linvoseltamab é seguro e bem tolerado e como funciona em participantes com mieloma múltiplo diagnosticado recentemente que ainda não receberam tratamento. (LINKER-MM4)
5 de novembro de 2026 atualizado por: Regeneron Pharmaceuticals
Estudo de Fase 1/2 de Linvoseltamab (anticorpo biespecífico anti-BCMA X anti-CD3) em pacientes previamente não tratados com mieloma múltiplo sintomático
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).
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
148
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Barcelona, Espanha, 08036
- Hospital Clinic de Barcelona
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Barcelona, Espanha, 08908
- Institut Catala dOncologia (ICO Hospitalet)
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Madrid, Espanha, 28027
- Clinica Universidad de Navarra - Madrid
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Madrid, Espanha, 28006
- Universitary Hospital La Princesa
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Salamanca, Espanha, 37007
- Hospital Universitario de Salamanca
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Valencia, Espanha, 46026
- Hospital Universitari i Politecnic La Fe
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Barcelona
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Badalona, Barcelona, Espanha, 08916
- Hospital Germans Trias i Pujol
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Madrid
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Pozuelo de Alarcón, Madrid, Espanha, 28223
- Hospital Universitario Quiron Salud Madrid
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Navarre
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Pamplona, Navarre, Espanha, 31008
- Clinica Universidad de Navarra
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Principality of Asturias
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Oviedo, Principality of Asturias, Espanha, 33011
- Hospital Universitario Central de Asturias
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Valencia
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Alicante, Valencia, Espanha, 03010
- Hospital General Universitario Doctor Balmis Alicante
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California Los Angeles (UCLA)
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Orange, California, Estados Unidos, 92868
- UC Irvine Health
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Colorado Blood Cancer Institute/SCRI
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Rutgers Cancer Institute of New Jersey
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New York
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Mineola, New York, Estados Unidos, 11501
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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New York, New York, Estados Unidos, 10016
- Perlmutter Cancer Center
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New York, New York, Estados Unidos, 10032
- Columbia University _ New York Presbyterian
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Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Hospital
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Levine Cancer Institute
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Durham, North Carolina, Estados Unidos, 27705
- Duke University Health System (DUHS)
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
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Lille, França, 59000
- CHU De Lille
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Montpellier, França, 342950
- Centre Hospitalier Universitaire (CHU) Montpellier
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Paris, França, 75010
- Hopital Saint Louis
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Paris, França, 75651
- University Hospitals Pitie Salpetriere - Charles Foix
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Vienne
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Poitiers, Vienne, França, 86021
- Centre Hospitalier Universitaire (CHU) de Poitiers
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Île-de-France Region
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Antony, Île-de-France Region, França, 92160
- Hopital Prive d'Antony
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Paris, Île-de-France Region, França, 75015
- Hopital Necker
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Villejuif, Île-de-France Region, França, 94800
- Gustave Roussy
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Dose-Limiting Toxicities (DLTs)
Prazo: 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)
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of TEAEs
Prazo: 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)
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of AESIs
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to 5 years
|
Phase 2 Transplant ineligible cohort |
Up to 5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concentrations of Linvoseltamab in serum
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to 5 years
|
Phase 1 |
Up to 5 years
|
|
Duration Of Response (DOR) measured using the IMWG criteria
Prazo: 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
Prazo: 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
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 1 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of TEAEs
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of TEAEs
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of AESIs
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Severity of AESIs
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
ORR by risk levels
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
MRD-negative status by risk levels
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
DOR by risk levels
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
TTR by risk levels
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
PFS by risk levels
Prazo: Post-Last Linvoseltamab Dose, up to 90 days
|
Phase 2 |
Post-Last Linvoseltamab Dose, up to 90 days
|
|
Incidence of MRD-negative status
Prazo: Up to 5 years
|
Phase 2 |
Up to 5 years
|
|
Cluster of Differentiation 34+ (CD34+) stem cell yield
Prazo: 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
Prazo: Up to 100 days post-transplant
|
Phase 2 Transplant-eligible cohort |
Up to 100 days post-transplant
|
|
Time to platelet engraftment
Prazo: 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
Prazo: Up to 5 years
|
Phase 2 Transplant-eligible cohort |
Up to 5 years
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Clinical Trial Management, Regeneron Pharmaceuticals
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de dezembro de 2023
Conclusão Primária (Estimado)
2 de novembro de 2035
Conclusão do estudo (Estimado)
2 de novembro de 2035
Datas de inscrição no estudo
Enviado pela primeira vez
12 de abril de 2023
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de abril de 2023
Primeira postagem (Real)
25 de abril de 2023
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de novembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de novembro de 2026
Última verificação
1 de novembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Doenças hemic e linfáticas
- Mieloma múltiplo
Outros números de identificação do estudo
- R5458-ONC-2158
- 2022-500800-24-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Prazo de Compartilhamento de 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
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .