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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)

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06154317
Enrollment
30
Registered
2023-12-04
Start date
2023-02-16
Completion date
2025-02-28
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

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.

Interventions

None listed

Sponsors

Centro di Riferimento Oncologico - Aviano
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of SOX4 and XBP1 expression in plasma cells from patient with MMup to 2 yearsFrequencies 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.

Countries

Italy

Contacts

Primary ContactMariagrazia Michieli, MD
mmichieli@cro.it0434 659 020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026