Relevancia de [68Ga]Ga-PentixaFor-PET para la estadificación inicial y la evaluación terapéutica del mieloma múltiple en el tratamiento de primera línea (PentiMyelo)
Estudio exploratorio que evalúa la relevancia de [68Ga]Ga-PentixaFor para la estadificación inicial y la evaluación terapéutica de pacientes con mieloma múltiple sintomático en tratamiento de primera línea
The aim of our study is to confirm the relevance of PET using [68Ga]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Bordeaux, Francia
- CHU Bordeaux
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Nantes, Francia
- Nantes UH
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Paris, Francia
- APHP - Site Tenon
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
- Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
- ECOG (Eastern Cooperative Oncology Group) < 2
- Patient affiliated to or beneficiary of the National Health Service
Exclusion Criteria:
- HIV positive, active Hepatitis B or C
- Childbearing or child breast feeding women
- Women or men without effective contraceptive barrier if needed
- eGFR < 50 ml/min by MDRD or CKDEPI
- Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Known active infection
- Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
- Patient under guardianship or trusteeship
- Patient under judicial protection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: [68Ga]Ga-PentixaPara
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Tomography by emission of positons (PET) with theradiopharmaceutic [68Ga]Ga-PentixaFor |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.
Periodo de tiempo: 1 Month
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Sensitivity will be assessed by patient and lesion analysis by defining:
|
1 Month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET
Periodo de tiempo: 1 Month
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The specificity (PPV and NPV) of [68Ga]Ga-PentixaFor-PET at the time of initial diagnosis will be assessed by patient and lesion analysis using the same definitions of TP and FN as for the primary objective. |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique
Periodo de tiempo: 1 Month
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The prognostic impact of PET-FDG and [68Ga]Ga-PentixaFor-PET based on the number of lesions detected and their intensity of uptake by each imaging technique will be evaluated by assessing the impact of these data on the PFS and OS. PFS is defined as the time from the start of treatment to relapse or progression. OS is defined as the time from the start of first treatment to death. |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET
Periodo de tiempo: 1 Month
|
Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET |
1 Month
|
|
To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET
Periodo de tiempo: 1 Month
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Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET |
1 Month
|
|
To determine at the initial diagnosis or relapse, the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding
Periodo de tiempo: 1 Month
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68Ga]Ga -PentixaFor and FDG uptakes assessed by SUV and the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases). |
1 Month
|
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To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
Periodo de tiempo: 1 Month
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Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga-PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga -PentixaFor injection before acquisition (at 60 min) |
1 Month
|
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To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
Periodo de tiempo: 1 Month
|
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patientat the end of acquisition (at approximately 80 min). |
1 Month
|
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To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.
Periodo de tiempo: 100 Day or 6 Month
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Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET |
100 Day or 6 Month
|
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To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
Periodo de tiempo: 100 Day and 6 Month
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The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS. |
100 Day and 6 Month
|
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To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
Periodo de tiempo: Every 6 months after the end of treatment
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The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS. |
Every 6 months after the end of treatment
|
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To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry
Periodo de tiempo: 100 Day or 6 Month
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PET-FDG, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative). |
100 Day or 6 Month
|
|
To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET
Periodo de tiempo: 100 Day or 6 Month
|
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga -PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min). |
100 Day or 6 Month
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- 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
- Enfermedades hemic y linfáticas
- Mieloma múltiple
Otros números de identificación del estudio
- RC19_0289
- 2024-516752-18-00 (Ctis)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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