Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

NCT05888636 | Recruiting

• 1 other identifier: RS1237
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

MGUS

Other: ChIP-seq, NGS, ATAC-seq

MM smouldering

Other: ChIP-seq, NGS, ATAC-seq

Syntomatic MM

Other: ChIP-seq, NGS, ATAC-seq

Interventions

ChIP-seq, NGS, ATAC-seq OTHER

Bone narrow sampling

MGUS; MM smouldering; Syntomatic MM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- Compare Transcriptomics and epigenetic profile

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Campus Bio-Medico University: collaborator
• University of Rome Tor Vergata: collaborator
• S.Eugenio Hospital: collaborator

Study Sites (2)

Regina elena Cancer Institute

Roma, 00144, Italy

ACTIVE NOT RECRUITING

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Chromatin Immunoprecipitation Sequencing

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

Intervention Hierarchy (Ancestors)

Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques

Study Officials

• Maurizio Fanciulli, PhD

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Fanciulli, PhD

CONTACT

*39 06 52662800; maurizio.fanciulli@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: June 5, 2023
• Study Start: June 18, 2019
• Primary Completion: November 11, 2023
• Study Completion: December 31, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

IT (2)