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A Study in Participants With Relapsed or Refractory Multiple Myeloma for QLS4131

6 de novembro de 2026 atualizado por: Qilu Pharmaceutical Co., Ltd.

A Phase 3 Randomized Study Comparing QLS4131 Injection Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this clinical trial is to evaluate the efficacy and safety of QLS4131 compared with the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of QLS4131 compared to the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma who have previously received 1-4 lines of therapy and have been exposed to three classes of drugs (proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies). The plan is to enroll approximately 300 participants, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Approximately 150 participants in the experimental group will receive QLS4131 treatment, while about 150 participants in the control group will receive the investigator's choice of treatment (DPd or PVd).

Tipo de estudo

Intervencional

Inscrição (Estimado)

300

Estágio

  • Fase 3

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

  • Nome: LUGUI QIU, Doctor of Medicine (MD)
  • Número de telefone: 022-23608124
  • E-mail: qiulg@ihcams.ac.cn

Estude backup de contato

  • Nome: GANG AN, Doctor of Medicine (MD)
  • Número de telefone: 13502181109
  • E-mail: angang@ihcams.ac.cn

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

Inclusion Criteria:

  • Age ≥18 years.
  • Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
  • At least one of the following measurable disease indicators:
  • Serum M-protein ≥ 5 g/L
  • Urine M-protein ≥200 mg/24h
  • Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio.
  • Received 1-4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).
  • Willing and able to comply with the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Prior treatment with both the BCMA-targeted therapy and the GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy alone are eligible.
  • Known hypersensitivity to any of the ingredients of investigational drug.
  • Diagnosis of plasma cell leukemia(peripheral blood plasma cells ≥5%),or primary light chain amyloidosis.
  • Known active central nervous system (CNS) involvement, or clinical signs and symptoms suggestive of meningeal involvement by multiple myeloma.

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: QLS4131

Participants will receive QLS4131 injection until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

QLS4131 will be administered subcutaneously.

Comparador Ativo: The investigator's choice regimen (DPd or PVd )

Participants will receive DPd or PVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21;The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle.

The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.

The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.

The DPd treatment regimen, one cycle every 28 days: Dexamethasone 20 mg orally, on days 1, 2, 8, 9, 15, 16, 22, and 23 (total 40 mg per week).

The PVd treatment regimen, one cycle every 21 days: Dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, and 12 of cycles 1-8, and on days 1, 2, 8, and 9 from cycle 9 onwards.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
PFS assessed by independent review committee
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

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 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
PFS assessed by investigator
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

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 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Very good partial response or better rate
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Very good partial response or better rate is defined as the percentage of participants who achieve very good partial response or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Negativity rate of minimal residual disease (MRD)
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Defined as the proportion of participants achieving MRD-negative status.

up to 2 years after the last enrolled participant receives the first dose of study drug
Sustained MRD negativity rate
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year.

up to 2 years after the last enrolled participant receives the first dose of study drug
6-month MRD negativity rate
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization.

up to 2 years after the last enrolled participant receives the first dose of study drug
12-month MRD negativity rate
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization.

up to 2 years after the last enrolled participant receives the first dose of study drug
Objective response rate
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Objective response rate is defined as the percentage of participants who achieve PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Complete response or better rate
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Complete response or better rate is defined as the percentage of participants who achieve CR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Duration of response
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

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 progressive disease according to the IMWG 2016 response criteria or death from any cause.

up to 2 years after the last enrolled participant receives the first dose of study drug
PFS Rate at 6, 12, and 18 Months
Prazo: 6, 12, and 18 months after randomization

Percentage of participants who remain alive and progression-free at 6, 12, and 18 months after randomization, as assessed by both the independent review committee (IRC) and the investigator according to IMWG 2016 response criteria.

6, 12, and 18 months after randomization
Overall survival
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

up to 2 years after the last enrolled participant receives the first dose of study drug
OS Rate at 12 and 24 Months
Prazo: 12 and 24 months after randomization

Percentage of participants who remain alive at 12 and 24 months after randomization.

12 and 24 months after randomization
Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Number of participants with AEs by Severity will be reported.

up to 2 years after the last enrolled participant receives the first dose of study drug
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Prazo: up to 2 years after the last enrolled participant receives the first dose of study drug

Change from baseline scores

up to 2 years after the last enrolled participant receives the first dose of study drug

Colaboradores e Investigadores

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

Patrocinador

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)

30 de dezembro de 2026

Conclusão Primária (Estimado)

14 de dezembro de 2029

Conclusão do estudo (Estimado)

21 de maio de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

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

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