Study for Validation of Target Therapy in Multiple Myeloma Cells From Patients With miRNAs Released From B Cells, and Study of the Bone Marrow Tumor Microenvironment (Microenvironment of MM)

Multiple Myeloma Clinical Trial

Official title:

Study for Validation of Target Therapy in Multiple Myeloma Cells From Patients With miRNAs Released From B Cells, and Study of the Bone Marrow Tumor Microenvironment (Microenvironment of MM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154317
• Other study ID #: CRO-2021-31
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Mariagrazia Michieli, MD
• Phone: 0434 659 020
• Email: mmichieli[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multiple Myeloma (MM) is a hematologic cancer caused by the selective clonal expansion of plasma cells. By acting on the microenvironment of the bone marrow, MM shifts the niche balance and becomes chemoresistant due to its interaction with stromal cells. Despite new therapeutic strategies, MM still remains incurable and new strategies are urgently needed. In order to successfully act on MM, we must use a strategy that reflects its plasticity and blocks it on several targets: proliferation, interaction with the microenvironment, and metastasis.

The main interest of the project is to evaluate the effect of gene therapy identified in vitro, directly on patient-derived samples, in particular to translate the knowledge gained on myeloma cell lines in vitro to primary tumor cells taken from patients.

Description:

Multiple Myeloma (MM) is a hematologic cancer caused by the selective clonal expansion of plasma cells. By acting on the microenvironment of the bone marrow, MM shifts the niche balance and becomes chemoresistant due to its interaction with stromal cells. Despite new therapeutic strategies, MM still remains incurable and new strategies are urgently needed. In order to successfully act on MM, we must use a strategy that reflects its plasticity and blocks it on several targets: proliferation, interaction with the microenvironment, and metastasis.

The main interest of the project is to evaluate the effect of gene therapy identified in vitro, directly on patient-derived samples, in particular to translate the knowledge gained on myeloma cell lines in vitro to primary tumor cells taken from patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age=18 years;

• Diagnosis of multiple myeloma for which a bone marrow biopsy is scheduled for practice

• Patients able to express appropriate consent to participation in the study (e.g., able to understand Italian, patient with intact cognitive abilities).

Exclusion Criteria:

• Absence of signed informed consent form

• Inadequate or insufficient bone marrow biopsy material

Related Conditions & MeSH terms

• Bone Marrow Neoplasms
• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Aviano	Pordenone

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of SOX4 and XBP1 expression in plasma cells from patient with MM	Frequencies and 95% confidence interval of SOX4 and XBP1, evaluated in plasma cells from bone biopsies and isolated from bone marrow blood of MM patients by qRT-PCR at different staging.	up to 2 years