Immune Profiling in Multiple Myeloma

NCT04135079 | Completed

• 1 other identifier: IMMUNE-UNITO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study propose to investigate the immune repertoire of MM patients at the time of diagnosis vs. 1st vs. 2nd vs. 3rd relapse. This study will provide insights into the immune status of MM patients before and after disease transformation and help identify patients who will benefit from immunotherapy. It will also allow us to predict the efficacy of these immune-mediated strategies and their associated toxicity. By understanding the immune-microenvironment in MM patients during disease progression, the investigator will be able to better design immunotherapeutic strategies for maximal success.

Conditions

Multiple Myeloma

Keywords

immune transcriptome profile; Drop-seq; immune signatures; CyTOF; cytokine profile

Outcome Measures

Primary Outcomes (1)

• Determine the immune transcriptome profile in the peripheral blood of MM patients at diagnosis and relapse by bulk and single cell RNAseq.

  PBMC samples will be subjected to bulk and single cell RNA sequencing for a comprehensive analysis of their immune transcriptomes, including but not limited to the gene expression profiles of high-resolution subsets of B cell, T cell, NK cell and myeloid compartments.

  through study completion, an average of 2 years

Secondary Outcomes (1)

• Determine the immune signatures in the peripheral blood of MM patients at diagnosis and relapse by time-of-flight mass cytometry (CyTOF).

  through study completion, an average of 2 years

Other Outcomes (1)

• Evaluate the cytokine profile in the peripheral blood of MM patients at diagnosis and relapse by cytokine arrays.

  through study completion, an average of 2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

newly diagnosed, and/or refractory MM patients and healthy donors

You may qualify if:

• newly diagnosed MM patients or
• refractory MM patients or
• healthy donors.
• Esclusion criteria:
• not newly diagnosed MM patients or
• not refractory MM patients or
• no healthy donors.

Sponsors & Collaborators

• Mario Boccadoro: lead

Study Sites (1)

Aou Citta' Della Salute E Della Scienza Di Torino

Torino, TO, 10126, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alessandra Larocca

  S.C. Ematologia U

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: October 22, 2019
• Study Start: April 15, 2019
• Primary Completion: April 28, 2021
• Study Completion: December 16, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

IT (1)