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Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients (CHAMPION-01)

17 de junho de 2026 atualizado por: Peng Liu, Shanghai Zhongshan Hospital

A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients

Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China.

And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients

Participants will:

Receive Isatuximab 10 mg/kg iv

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m²
  • Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day
  • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Receive Dexamethasone oral 20 mg
  • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.

During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.

During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This is a single-arm, multicenter, prospective observational cohort study with a planned total enrollment of 333 transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients aged ≥18 years old in China. All enrolled participants will receive the Isa-VRd induction regimen for 8 cycles (4 weeks per cycle, total 32 weeks). After induction therapy, investigators will determine whether patients continue maintenance treatment based on individual response status, followed by a 2-year long-term follow-up period from the initiation of Isa-VRd treatment, with the maximum observation window of each subject capped at 24 months.

For efficacy evaluation, minimal residual disease (MRD) testing with a cutoff of NGF=10-⁵ will be performed at multiple prespecified time points: at month 8 post-induction, and every 6 months throughout the maintenance and follow-up phase (at months 14, 20 and 26). The primary endpoint of this study is ≥CR rate after induction therapy. Secondary efficacy endpoints include stringent complete response (sCR), very good partial response (VGPR), overall response rate (ORR), duration of response (DOR), time to response (TTR), time to next treatment (TNT), progression-free survival (PFS), overall survival (OS), as well as all safety and tolerability outcomes.

Throughout the entire treatment and follow-up period, all treatment-emergent adverse events (TEAEs), grade ≥3 adverse events, serious adverse events (SAEs), and adverse events of special interest (AESIs, including infusion reactions and second primary malignancies) will be continuously collected and recorded to evaluate the real-world safety profile of the Isa-VRd regimen in Chinese TI-NDMM patients. The overall planned study duration spans approximately 24 months from the first subject's enrollment to the completion of the last patient's 24-month follow-up assessment.

Tipo de estudo

Observacional

Inscrição (Estimado)

333

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

Estude backup de contato

Locais de estudo

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recrutamento
        • Sun Yat-sen University Cancer Center
        • Contato:
      • Shenzhen, Guangdong, China
    • Guangxi
      • Naning, Guangxi, China, 450000
        • Recrutamento
        • The First Affiliated Hospital of Guangxi Medical University
        • Contato:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recrutamento
        • Harbin Institute of Hematologic Oncology
        • Contato:
    • Henan
    • Hubei
      • Wuhan, Hubei, China
        • Recrutamento
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
        • Contato:
    • Jiangsu
      • Nanjing, Jiangsu, China
      • Nantong, Jiangsu, China
        • Recrutamento
        • Affiliated Hospital of Nantong University
        • Contato:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recrutamento
        • Fudan University Affiliated Zhongshan Hospital
        • Contato:
    • Shanxi
      • Xi’an, Shanxi, China
    • Sichuan
    • Yunnan
      • Kunming, Yunnan, China
        • Recrutamento
        • The First Affiliated Hospital of Kunming Medical University
        • Contato:

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

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients (≥18 years old) with newly diagnosed multiple myeloma, ineligible for autologous stem cell transplantation due to age or comorbidities, who are scheduled to receive the Isatuximab + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd) combination regimen.

Descrição

Inclusion Criteria:

  • Age ≥18 years
  • Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines

  • Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):

    • Absolute neutrophil count (ANC) ≥1.0×10⁹/L
    • Platelet count ≥50×10⁹/L
    • Calculated creatinine clearance ≥30 mL/min (using Cockcroft-Gault formula)
    • Total bilirubin ≤3× upper limit of normal (ULN)
  • TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)

Exclusion Criteria:

  • Patients currently participating in other interventional clinical studies
  • Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients
  • Severe bacteremia at the time of administration

  • Currently uncontrolled cardiovascular disease, including:

    • Uncontrolled hypertension
    • Uncontrolled arrhythmia
    • Uncontrollable congestive heart failure
    • Unstable angina
  • Patients with peripheral neuropathy ≥Grade 2
  • Active infectious disease, known human immunodeficiency virus (HIV) positivity, active hepatitis B or hepatitis C
  • Patients who are currently pregnant
  • Patients who, at the physician's discretion, are unable to tolerate any drug in the combination regimen

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

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen

Arm Description:

Isatuximab 10 mg/kg Intravenous injection

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg/m²
  • Cycles 1-8: Days 1, 8, and 15 of each cycle Lenalidomide oral 25 mg/day
  • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Dexamethasone oral 20 mg
  • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen
Medicamento: Isatuximab

Isatuximab 10 mg/kg Intravenous (IV) infusion

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally.
Outros nomes:
  • sarclisa
Medicamento: Bortezomib

Bortezomib subcutaneous injection 1.3 mg/m²

• Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

Outros nomes:
  • Velcade, PS-341
Medicamento: Lenalidomide

Lenalidomide oral 25 mg/day

• Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Following Cycle 8, the investigator may assess and adjust the treatment regimen

Outros nomes:
  • Revlimid
Medicamento: Dexamethasone

Dexamethasone oral 20 mg

• Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

Outros nomes:
  • Decadron

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
≥CR rate after induction treatment
Prazo: After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)
The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.
After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
MRD negativity rate
Prazo: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
≥VGPR rate
Prazo: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
Overall response rate
Prazo: At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
Duration of Response
Prazo: From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Time to Response
Prazo: Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Duration of Treatment
Prazo: Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Progression free survival
Prazo: Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Overall Survival
Prazo: Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Incidence Adverse Events
Prazo: From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.
Adverse events (AEs) include treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs), defined as infusion reactions (IRs) and occurrence of second primary malignancies.
From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.

Colaboradores e Investigadores

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

Patrocinador

Shanghai Zhongshan Hospital

Investigadores

  • Investigador principal: Peng Liu, Fudan University

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 (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

5 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2026

Primeira postagem (Real)

23 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • B2026-229

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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 .

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