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)

Sponsor
Centro di Riferimento Oncologico - Aviano (Other)
Overall Status
Recruiting
CT.gov ID
NCT06154317
Collaborator
(none)
30
1
23.5
1.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    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)
    Actual Study Start Date :
    Feb 16, 2023
    Anticipated Primary Completion Date :
    Feb 1, 2025
    Anticipated Study Completion Date :
    Feb 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of SOX4 and XBP1 expression in plasma cells from patient with MM [up to 2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Ageā‰„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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS Aviano Pordenone Italy 33081

    Sponsors and Collaborators

    • Centro di Riferimento Oncologico - Aviano

    Investigators

    • Principal Investigator: Mariagrazia Michieli, MD, Centro di Riferimento Oncologico (CRO) di Aviano-IRCCS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centro di Riferimento Oncologico - Aviano
    ClinicalTrials.gov Identifier:
    NCT06154317
    Other Study ID Numbers:
    • CRO-2021-31
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 4, 2023