Investigate eNAMPT in Multiple Myeloma Biology and Establish Its Role in Disease Progression

NCT04137523 | Completed

• 1 other identifier: eNAMPT
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Based on our previous observations, here the investigator plans to further investigate eNAMPT in MM biology and to establish its role in disease progression where EMT acquisition represents an hallmark of cancers. Results deriving from proposal would hopefully identify novel biological vulnerabilities of such malignancy and an innovative biomarker for disease progression monitoring as well.

Conditions

Multiple Myeloma

Keywords

potential marker; cytokine/adipokine; multiple myeloma

Outcome Measures

Primary Outcomes (5)

• To strengthen preliminary data

  To strengthen preliminary data and to investigate the correlation between eNAMPT levels in BM and peripheral blood (PB) compartments by assessing its concentration in paired samples collected from a larger cohort of NDMM patients, using also more HDs as control.

  2 years

• Potential marker of PD

  To disclose eNAMPT relevance as potential marker of disease progression by comparing eNAMPT plasmatic levels from samples collected in different phases of disease (MGUS, Smoldering Multiple Myeloma -SMM-, NDMM, relapsed/refractory MM) and by their correlation with available clinical data.

  2 years

• Analysis both MM cells and MM-BMSC compartment.

  To investigate cellular source of eNAMPT production in MM by analyzing both MM cells (Established Human Myeloma Cell Lines, HMCLs and primary CD138+ cells) and MM-BMSC compartment.

  2 years

• To investigate eNAMPT role

  To investigate eNAMPT role in EMT features acquisition of HMCLs (with known molecular features such as karyotype status, mutations, drug-resistance phenotype etc.) and to define the underlying molecular mechanisms.

  2 years

• To determine the effects

  To determine the effects of previously identified neutralizing αeNAMPT antibody (Ab) (13) on MM cells both in vitro and in an in vivo MM-xenografted mouse model.

  2 years

Eligibility Criteria

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

Study Population

100 MM patient samples will be selected from previous clinical trials that have been conducted over the past 5 years.

You may qualify if:

• Male and female patients over 18 years of age;
• PB-derived serum samples collected in different disease phases (MGUS, SMM, NDMM and RRMM MM patients)
• Sufficient CD138+ cells or RNA from CD138+ cells are available;
• ≥ 2 years median survival data and treatment data is available (progression free and overall survival);
• Bone marrow sample acquired prior to the initiation of the therapy of interest;
• Patients have consented for use of their sample for research purposes.

Sponsors & Collaborators

• University of Turin, Italy: 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 Design

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

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: August 12, 2019
• Primary Completion: August 12, 2019
• Study Completion: December 10, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

IT (1)