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

• Sponsor: Regina Elena Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05888636
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 54.4
• Patients Per Site: 100
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: ChIP-seq, NGS, ATAC-seq

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Transcriptomics and Epigenetics Analysis for Biomarkers Identification Involved in Drug-resistance Mechanisms of Multiple Myeloma
• Actual Study Start Date: Jun 18, 2019
• Actual Primary Completion Date: Dec 12, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Compare Transcriptomics and epigenetic profile

Exclusion Criteria:

• No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regina elena Cancer Institute	Roma		Italy	00144
2	"Regina Elena" National Cancer Institute	Rome		Italy	00144

Sponsors and Collaborators

• Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regina Elena Cancer Institute
• ClinicalTrials.gov Identifier: NCT05888636
• Other Study ID Numbers: RS1237
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jun 5, 2023