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NCT05888636 Clinical Trial

Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

Multiple Myeloma Clinical Trial

— TEDROMM  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05888636
Other study ID # RS1237
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 18, 2019
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Regina Elena Cancer Institute
Contact Maurizio Fanciulli, PhD
Phone *39 06 52662800
Email maurizio.fanciulli@ifo.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date November 11, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Compare Transcriptomics and epigenetic profile Exclusion Criteria: - No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ChIP-seq, NGS, ATAC-seq
Bone narrow sampling

Locations
Country Name City State
Italy Regina elena Cancer Institute Roma
Italy "Regina Elena" National Cancer Institute Rome

Sponsors (4)
Lead Sponsor Collaborator
Regina Elena Cancer Institute Campus Bio-Medico University, Sant'Eugenio Hospital, Rome, University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

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