Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06463717

Reclutando

Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not

Observacional

Fase no especificada

The First Affiliated Hospital of Zhejiang University

Patrocinador: First Affiliated Hospital of Zhejiang University

Última actualización: 24 de junio de 2024
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

The goal of this observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction.

The main question it aims to answer is:

In primary multiple myeloma patients who achieved MRD negativity after induction, non ASCT regimens are not inferior to ASCT or not? Participants will receive ASCT or non ASCT regimen according to their own choice.

Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety.

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Categoría de tratamiento

Otros medicamentos, Quimioterapia

Erforderliche Mutationen

Ninguna

Ensayo iniciado

1 de diciembre de 2023

Última actualización por el patrocinador

24 de junio de 2024

Finalización estimada

1 de noviembre de 2028

Contacto del estudio

Nombre:Liangshun You

Correo electrónico:youliangshun@zju.edu.cn

Teléfono:+86 15088687797

Nombre:Qiumei Yao

Correo electrónico:qiumei_yao@163.com

Teléfono:+86 13867490514

Elegibilidad

Criterios de inclusión

1. Newly diagnosed multiple myeloma according to the criteria of International Working Group of Myeloma

2. Age ranges from 18-70 years old

3. Achieved MRD negativity and at least very good partial response in clinical response after 4-6 courses of induction therapy. MRD is measured by MRD by multicolor flow with a sensitivity of 10-5.

4. At enrollment, score of Eastern Cooperative Oncology Group (ECOG) should be 0-2.

5. Organ function requirement: Blood bilirubin ≤ 2mg/dL (35 μ mol/L), Alanine aminotransferase/Aspartate aminotransferase below 2 times the upper limit of normal value, Creatinine clearance rate (Ccr) ≥ 30ml/min and Cardiac ejection fraction ≥50%.

6. Expected survival more than 3 months.

Criterios de exclusión

1. Two or more high-risk cytogenetic abnormalities, including del (17p), t (4; 14), t (14; 16), del (1p), amp (1q). Fluorescence in situ hybridization was used to analyze CD138 positive sorted cells, with cut off value of 15% for translocation, 10% for deletion, and amp (1q) of 20%.

2. Extracellular plasma cell disease, central invasion of myeloma, plasma cell leukemia

3. History of other malignant tumors within the past 5 years

4. Patients with HIV, active tuberculosis, clinically active hepatitis A, B, or C

5. Other serious condition that may restrict patients from continuing treatment (such as advanced infection, uncontrolled diabetes, severe cardiac insufficiency, or angina pectoris)

7. Pregnant or lactating women

8. Suffering from other serious organic diseases and mental disorders.

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónN/A

EnmascaramientoN/A

Número a inscribir210

Brazos e Intervenciones

Brazos

Intervenciones

Tipo:

Descripción: Primary multiple myeloma patients who receive autologous hematopoietic stem-cell transplantation (ASCT) after they achieved MRD negativity after induction

Intervenciones:

Transplant, Autologous
Chemotherapy drug

Medidas de resultado

Medidas de resultado primarias

progression free survival2-year

Progression-free survival is defined as the duration from diagnosis to the date of death, initial progression, or the last follow-up

Medidas de resultado secundarias

sustain MRD negativity1-year, 2-year

The proportion of patients who are still MRD negative at 1-year, 2-years after achieving MRD negativity after induction therapy

Number of Participants With Treatment-Related Adverse EventsOnce enrolled, an average of 2 year

All adverse events and second primary malignancies

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, CN

Nombre:Liangshun You

Reclutando

Hangzhou, Zhejiang, 310000 CN

The First Affiliated Hospital of Zhejiang University

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