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A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).

30 de julho de 2026 atualizado por: Peng Liu, Shanghai Zhongshan Hospital

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)

The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL). It will also learn about the safety of this combination. The main questions it aims to answer are:

Does Tec-Dara improve the 1-year progression-free survival rate compared to historical data (50% to 75%) in MM+AL patients? What are the rates of hematologic response (ORR, VGPR, CR, MRD negativity) and organ response in MM+AL patients treated with Tec-Dara? What medical problems do participants have when taking Tec-Dara?

Participants will:

Receive teclistamab subcutaneous injection with step-up dosing (0.06, 0.3, 1.5 mg/kg), followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24 Receive daratumumab subcutaneous injection 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24 Continue treatment until disease progression, unacceptable toxicity, or a maximum of 24 cycles Undergo disease assessments every 28 days (±7 days) including laboratory tests for hematologic and organ response evaluation Provide bone marrow samples for MRD and RNA sequencing analysis

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

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

Estude backup de contato

Locais de estudo

  • China
      • Shanghai, China
        • Recrutamento
        • Zhongshan Hospital Fudan 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

Descrição

Inclusion Criteria:

  1. Age ≥18 years, any sex/gender
  2. Diagnosis of multiple myeloma according to IMWG criteria

  3. Histopathologic diagnosis of AL amyloidosis confirmed by:

    • Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:

      1. Immunohistochemistry and/or immunofluorescence
      2. Mass spectrometry
      3. Electron microscopy/immunoelectron microscopy
  4. Measurable disease at screening
  5. Newly diagnosed, no prior anti-plasma cell therapy

  6. Adequate laboratory values:

    • Hemoglobin ≥7.5 g/dL
    • Absolute neutrophil count ≥1.0×10⁹/L
    • Platelet count ≥70×10⁹/L (platelet transfusion acceptable; >50×10⁹/L if ≥50% bone marrow nucleated cells are plasma cells)
    • ALT ≤2.5× upper limit of normal (ULN)
    • AST ≤2.5× ULN
    • Total bilirubin ≤2.0× ULN
    • Creatinine clearance ≥30 mL/min
    • Corrected serum calcium ≤14 mg/dL
  7. Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
  8. Voluntarily signed informed consent form (ICF)

Exclusion Criteria:

  1. Prior anti-myeloma therapy or stem cell transplantation
  2. Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or other malignancies within 3 years prior to enrollment
  3. Active infection or autoimmune disease
  4. Uncontrolled diabetes, hypertension, or other comorbidities
  5. Pregnant or lactating female
  6. Currently participating in another interventional study
  7. Any other condition that the investigator considers unsuitable for study participation

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Treatment Group

Teclistamab (subcutaneous injection) with step-up dosing: 0.06 mg/kg, 0.3 mg/kg, and 1.5 mg/kg on Days 1, 3, and 5 of Cycle 1, followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24.

Daratumumab (subcutaneous injection) 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24.

Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 cycles (approximately 2 years).
Medicamento: Teclistamab

Teclistamab: A humanized IgG4-PAA bispecific antibody targeting BCMA and CD3. It bridges malignant plasma cells and CD3+ T cells, leading to T cell activation and perforin/granzyme-mediated lysis of BCMA+ tumor cells.

Daratumumab: A humanized IgG1κ monoclonal antibody targeting CD38, which induces tumor cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. It also enhances T cell-mediated anti-myeloma immunity by increasing cytotoxic T helper cells and depleting CD38+ immunoregulatory cells, thereby potentiating teclistamab's activity.

Outros nomes:
  • Daratumumabe

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
1-Year Progression-Free Survival (PFS) Rate
Prazo: From the start of treatment to 1 year, or until disease progression or death, whichever occurs first
The percentage of participants who are alive and free from disease progression at 1 year after initiation of Tec-Dara treatment. Progression is defined according to IMWG criteria, including increase in serum M protein, urine M protein, or serum free light chain; development of new bone lesions or soft tissue plasmacytomas; or hypercalcemia.
From the start of treatment to 1 year, or until disease progression or death, whichever occurs first

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hematologic Complete Response (Heme-CR) rate
Prazo: Up to 24 cycles (approximately 2 years)
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response. Heme-CR rate is the percentage of participants who achieve CR prior to subsequent anti-myeloma therapy, during or after the study treatment.
Up to 24 cycles (approximately 2 years)
Very Good Partial Response or Better (≥VGPR) Rate
Prazo: Up to 24 cycles (approximately 2 years)
Heme-VGPR is defined as a reduction in the dFLC to <40 mg/L. ≥VGPR rate is the percentage of participants achieving VGPR and CR prior to subsequent anti-myeloma therapy during or after the study treatment.
Up to 24 cycles (approximately 2 years)
Minimal Residual Disease (MRD) Negativity Rate
Prazo: 6 months and 12 months, and up to 24 cycles (approximately 2 years)
Proportion of participants achieving MRD negativity at a sensitivity threshold of 10^-5, assessed by next-generation flow cytometry (NGF) or next-generation sequencing (NGS). The MRD-negativity rate by 6 and 12 months will be reported descriptively.
6 months and 12 months, and up to 24 cycles (approximately 2 years)
Organ Response Rate
Prazo: Up to 24 cycles (approximately 2 years)
Proportion of participants achieving organ response according to consensus criteria for AL amyloidosis, based on changes in NT-proBNP, cardiac troponin T/I, and estimated glomerular filtration rate (eGFR).
Up to 24 cycles (approximately 2 years)
Time to First Response
Prazo: Up to 24 cycles (approximately 2 years)
Time from the start of treatment to the first documented PR or better response according to IMWG criteria.
Up to 24 cycles (approximately 2 years)
Duration of Response
Prazo: Up to 3 years from study start
Time from the start of treatment to death from any cause.
Up to 3 years from study start
Median Progression-Free Survival
Prazo: Up to 3 years from study start
Time from the start of treatment to disease progression or death from any cause, whichever occurs first.
Up to 3 years from study start
Time to Next Treatment
Prazo: Up to 3 years from study start
Time from the start of treatment to the initiation of first subsequent anti-myeloma therapy.
Up to 3 years from study start
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Prazo: Through study completion, up to 12 months after the end of study treatment.
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0. A participant with multiple adverse events of the same preferred term will be counted once. Adverse events will be summarized by frequency, severity (graded by CTCAE v5.0), and causality, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, hematologic toxicities, and infusion-related reactions.
Through study completion, up to 12 months after the end of study treatment.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Differential gene expression in bone marrow by RNA sequencing between baseline and disease progression in MM-AL patients.
Prazo: Baseline and up to 3 years.
Bone marrow transcriptome profiles will be analyzed by RNA sequencing at baseline and at disease progression to identify differentially expressed genes, altered signaling pathways, and molecular signatures predictive of disease progression in MM-AL patients. Data will be summarized as fold-change in gene expression, pathway enrichment scores, and predictive model performance metrics (e.g., AUC, sensitivity, specificity).
Baseline and up to 3 years.

Colaboradores e Investigadores

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

Patrocinador

Shanghai Zhongshan Hospital

Colaboradores

Johnson & Johnson

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 (Real)

22 de maio de 2026

Conclusão Primária (Estimado)

30 de julho de 2028

Conclusão do estudo (Estimado)

30 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SHZS-MMAL-001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

All IPD that underlie results in a publication

Prazo de Compartilhamento de IPD

starting 6 months after publication

Critérios de acesso de compartilhamento IPD

IPD could be requested by contacting the corresponding author via email after publication.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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