Clinical trial NCT06154317: 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)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sexes with multiple myeloma referred to the SOSD Oncoematologia, Trapianti emopoietici e Terapie cellulari of the CRO in Aviano.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of SOX4 and XBP1 expression in plasma cells from patient with MM
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico (CRO) di Aviano-IRCCS
name: Mariagrazia Michieli, MD
role: PRINCIPAL_INVESTIGATOR
References: