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A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma (TRI Pro)

27 de agosto de 2026 atualizado por: Janssen Research & Development, LLC

79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo. CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

230

Estágio

  • Fase 2

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.

Contato de estudo

Locais de estudo

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Recrutamento
        • Instituto Alexander Fleming
      • Buenos Aires, Argentina, C1118
        • Recrutamento
        • Hospital Aleman
      • Córdoba, Argentina, X5016KEH
        • Recrutamento
        • Hospital Privado Centro Medico de Cordoba
  • Austrália
      • Concord, Austrália, 2139
        • Recrutamento
        • Concord Repatriation General Hospital
  • Estados Unidos
    • California
      • Beverly Hills, California, Estados Unidos, 90211
        • Recrutamento
        • Beverly Hills Cancer Center (BHCC)
  • Malásia
      • Ampang, Malásia, 68000
        • Recrutamento
        • Hospital Ampang
      • Johor Bharu, Malásia, 80100
        • Recrutamento
        • Hospital Sultanah Aminah
      • Kota Kinabalu, Malásia, 88586
        • Recrutamento
        • Hospital Queen Elizabeth
      • Kuching, Malásia, 93586
        • Recrutamento
        • Sarawak General Hospital

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion criteria:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol
  • Received at least 1 prior lines of antimyeloma therapy
  • Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response (that is, partial response or better) or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy
  • Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

Exclusion criteria:

  • Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
  • Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
  • Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
  • Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM that is considered at high risk of recurrence requiring systemic therapy
  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm A: Tocilizumab + Ramantamig
Participants will receive tocilizumab alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
Medicamento: Ramantamig
Ramantamig will be administered as subcutaneous (SC) injection.
Outros nomes:
  • JNJ-79635322
Medicamento: Tocilizumab
Tocilizumab will be administered as intravenous (IV) injection.
Comparador de Placebo: Arm B: Placebo + Ramantamig
Participants will receive placebo (saline) alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).
Medicamento: Ramantamig
Ramantamig will be administered as subcutaneous (SC) injection.
Outros nomes:
  • JNJ-79635322
Medicamento: Placebo
Placebo (saline) will be administered as IV injection.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Alive and Free of Treatment-Emergent American Society for Transplantation and Cellular Therapy (ASTCT) Grade Greater Than or Equal to (>=) 2 Cytokine Release Syndrome (CRS)
Prazo: End of Day 28 from ramantamig dose
Percentage of participants alive and free of treatment-emergent ASTCT Grade >=2 CRS without the use of intervening treatment for CRS of any grade by the end of Day 28 from ramantamig dose will be reported.
End of Day 28 from ramantamig dose

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from Ramantamig Dose
Prazo: End of Day 28 from ramantamig dose
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the end of Day 28 from the ramantamig dose, respectively, will be reported.
End of Day 28 from ramantamig dose
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
Prazo: Up to 37 months
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
Up to 37 months
Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
Prazo: Up to approximately 3 years and 6 months
Percentage of participants with re-occurrence of CRS with ASTCT Grade >=2 after the initial occurrence of treatment-emergent Grade >=2 CRS event will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Re-occurrence of CRS for All Grades
Prazo: Up to approximately 3 years and 6 months
Percentage of participants with re-occurrence of CRS for all Grades will be reported.
Up to approximately 3 years and 6 months
Overall Response Rate (ORR)
Prazo: Up to approximately 3 years and 6 months
ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to progressive disease (PD) or subsequent antimyeloma therapy, in accordance with the international myeloma working group (IMWG) criteria.
Up to approximately 3 years and 6 months
Complete Response (CR) or Better
Prazo: Up to approximately 3 years and 6 months
CR or better rate is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
Up to approximately 3 years and 6 months
Very Good Partial Response (VGPR) or Better
Prazo: Up to approximately 3 years and 6 months
VGPR or better rate is defined as the percentage of participants achieving VGPR, CR or sCR prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
Up to approximately 3 years and 6 months
Duration of Response (DoR)
Prazo: Up to approximately 3 years and 6 months
DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD according to the IMWG response criteria or death due to any cause, whichever occurs first.
Up to approximately 3 years and 6 months
Time to Response (TTR)
Prazo: Up to approximately 3 years and 6 months
TTR is defined as the time from the date of randomization to the date of first documentation of a confirmed response (PR or better) for participants who have PR or better as their best response.
Up to approximately 3 years and 6 months
Progression-Free Survival (PFS)
Prazo: Up to approximately 3 years and 6 months
PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
Up to approximately 3 years and 6 months
Time To Next Line of Therapy (TTNT)
Prazo: Up to approximately 3 years and 6 months
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.
Up to approximately 3 years and 6 months
Time to the First Treatment-emergent Infection with Toxicity Grade >=3
Prazo: Up to approximately 3 years and 6 months
Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
Prazo: Up to approximately 3 years and 6 months
Percentage of participants with primary IgRT prophylaxis use will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
Prazo: Up to approximately 3 years and 6 months
Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Prazo: Up to approximately 3 years and 6 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent antimyeloma therapy, whichever is earlier, or any follow-up AE (linked to an existing TEAE) with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy, or any AE that is considered treatment-related regardless of the start date of the event, is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.
Up to approximately 3 years and 6 months
Percentage of Participants with Abnormalities in Laboratory Parameters
Prazo: Up to approximately 3 years and 6 months
Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
Up to approximately 3 years and 6 months
Percentage of Participants with Incidence of Adverse Events of Clinical Interests
Prazo: Up to approximately 3 years and 6 months
Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
Up to approximately 3 years and 6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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)

30 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2027

Conclusão do estudo (Estimado)

8 de novembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

11 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de maio de 2026

Primeira postagem (Real)

15 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 79635322MMY2002 (Outro identificador: Janssen Research & Development, LLC)
  • 2025 (Concessão/Contrato do NIH dos EUA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524793-42 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

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

produto fabricado e exportado dos EUA

Sim

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 .

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