A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003
28 de mayo de 2026 actualizado por: Innovent Biologics (Suzhou) Co. Ltd.
A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of IBI3003 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 255 participants, who will be randomly assigned to the experimental group and the control group in a 2:1 ratio.
Approximately 170 participants in the experimental group will receive IBI3003 treatment, while about 85 participants in the control group will receive the investigator's choice of treatment (DPd or PVd).
Participants in the experimental group can discontinue medication for observation after meeting the criteria for stopping treatment.
During the discontinuation period, if they meet the re-treatment criteria, following discussion between the investigator and the sponsor, and based on the participant's preference, IBI3003 re-treatment may be given until the criteria for terminating treatment are met.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
255
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Haiyan Zhu
- Número de teléfono: 0512-69566088
- Correo electrónico: haiyan.zhu@innoventbio.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 132101
- ZhongShan Hospital FuDan University
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Contacto:
- Peng Liu
- Número de teléfono: 021-3115199
- Correo electrónico: liu.peng@zs-hospital.sh.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）
- Urine M-protein ≥200 mg/24h
- Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (<0.26 or >1.65)
- Life expectancy ≥3 months.
- Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate <1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug.
- Willing and able to comply with the prohibitions and restrictions specified in this protocol.
Exclusion Criteria：
- Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.
- Have history of primary immunodeficiency.
- Have history of organ transplantation.
- Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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Experimental: IBI3003
participants will receive IBI3003 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.
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According to body weight
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS assessed by independent review committee
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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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
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS assessed by investigator
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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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
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Negativity rate of minimal residual disease (MRD)
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the proportion of participants achieving MRD-negative status
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Sustained MRD negativity rate
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year
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up to 24 months after the last enrolled participant receives the first dose of study drug
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6-month MRD negativity rate.
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization
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up to 24 months after the last enrolled participant receives the first dose of study drug
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12-month MRD negativity rate
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Objective response rate
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Complete response or better rate
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Very good partial response or better rate
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 criteria
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Duration of response
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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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 response criteria or death due to any cause, whichever occurs first
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Time to response
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the time from randomization to the date of the first tumor response assessment of PR or better among participants with a best overall response of PR or better
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Time to best response
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the time from randomization to the date of first documented Best Overall Response (BOR) among participants with a best overall response of PR or better
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Time to next treatment
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the time from initiation of study drug treatment to initiation of next-line therapy
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Overall survival
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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OS is defined as the time from the date of randomization to the date of the participant's death due to any cause
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Treatment-related Adverse Event (TRAE) by Severity
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Adverse Event of Special Interest (AESI) by Severity
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Number of Participants with Serious Adverse Event (SAE)
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Defined as the percentage of participants with SAE
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Periodo de tiempo: up to 24 months after the last enrolled participant receives the first dose of study drug
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Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported
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up to 24 months after the last enrolled participant receives the first dose of study drug
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de junio de 2026
Finalización primaria (Estimado)
31 de mayo de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Neoplasias
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Reaparición
- Mieloma múltiple
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Terapéutica
- Rutas de administración de drogas
- Terapia con drogas
- Químicos inorgánicos
- Ácidos borónicos
- Ácidos, no carboxílicos
- Ácidos
- Compuestos de boro
- Pirazinas
- Bortezomib
- Inyecciones
- pomalidomida
- daratumumab
- Inyecciones, subcutáneas
- Fumigante 93
Otros números de identificación del estudio
- CIBI3003A301
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .