Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma (TEDROMM)

March 20, 2024 updated by: Regina Elena Cancer Institute

Transcriptomics and Epigenetics Analysis for Biomarkers Identification Involved in Drug-resistance Mechanisms of Multiple Myeloma

Multiple Myeloma (MM) is the more common hematological neoplastic disease second only to Hodgkin lymphoma. In MM patients, mutated genes are mainly KRAS (23%), NRAS (20%), FAM46C (11%), DIS3 (11%) e TP53 (8%). Epigenetics studies suggested that Changes in histone modifications and DNA methylation pattern, as well as non-coding RNAs (miRNAs) expression are involved in MM development. In particular, it has been shown that the aberrant expression of different miRNAs could discriminate healthy from ill patients. Unfortunately, the main critical issue for an effective treatment of MM is the intrinsic or acquired resistance to pharmacological treatments, due also to a plasmacellular clonal heterogeneity.

The prospective study will involve a patient cohort with MGUS, MM smouldering and MM, with the aim to characterize different transcriptional and epigenetic features, also including miRNAs, among MM cells susceptible or resistant to conventional therapies. The final goal is to identify new prognostic and predictive biomarkers that could be used as therapeutic tools to improve clinical targeted therapies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy, 00144
        • Active, not recruiting
        • Regina Elena Cancer Institute
      • Rome, Italy, 00144
        • Recruiting
        • "Regina Elena" National Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

For the study, samples from patients with MGUS, MM smouldering and syntomatic MM will be used

Description

Inclusion Criteria:

- Compare Transcriptomics and epigenetic profile

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MGUS
Other: ChIP-seq, NGS, ATAC-seq
Bone narrow sampling
MM smouldering
Other: ChIP-seq, NGS, ATAC-seq
Bone narrow sampling
Syntomatic MM
Other: ChIP-seq, NGS, ATAC-seq
Bone narrow sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptomics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples
Time Frame: 12 months
Characterize genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement.
12 months
Epigenetics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples
Time Frame: 12 months
Quantify genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Collaborators

University of Rome Tor Vergata
Campus Bio-Medico University
Sant'Eugenio Hospital, Rome

Investigators

  • Principal Investigator: Maurizio Fanciulli, PhD, IRCCS "Regina Elena" National Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Actual)

November 11, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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