Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Other: ChIP-seq, NGS, ATAC-seq

• Registration Number: NCT05888636
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Primary Completion: 2023-11-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Compare Transcriptomics and epigenetic profile

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MGUS	ChIP-seq, NGS, ATAC-seq	-
MM smouldering	ChIP-seq, NGS, ATAC-seq	-
Syntomatic MM	ChIP-seq, NGS, ATAC-seq	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Regina elena Cancer Institute; 🇮🇹 Roma, Italy

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy