AATF/Che-1: Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment

• Sponsor: Regina Elena Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05858203
• Collaborator: (none)
• Enrollment: 150
• Locations: 2
• Anticipated Duration (Months): 60.3
• Patients Per Site: 75
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Multiple myeloma (MM) is a haematological malignancy characterized by the accumulation of proliferating antibody producing plasma cells in the bone marrow. In the last few years many studies have emphasized the biological complexity and heterogeneity of MM as a result of both genetic and epigenetic aberrations. Che-1/AATF (Che-1) is a transcriptional cofactor involved in cell cycle regulation, apoptosis, DNA damage and stress response. it can be hypothesized that Che-1 might contribute to the establishment of the MM malignant phenotype by sustaining global transcription through its ability to modulate chromatin accessibility.

The prospective study on MM human samples aims to understand the involvement of Che-1 in the transcriptional regulation and chromatin remodeling during the pathology. To this goal the main objectives are:

• Characterization of Che-1's role in chromatin remodeling and global gene expression

• Study in vivo and in vitro of Che-1 involvement in MM tumorigenesis

• Evaluation of Che-1 as a possible therapeutic target

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

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment
• Actual Study Start Date: Dec 22, 2020
• Actual Primary Completion Date: Mar 21, 2023
• Anticipated Study Completion Date: Dec 31, 2025

Outcome Measures

Primary Outcome Measures

1. Che-1 involvement in MM tumorigenesis [About 2 years]

   Characterization of Che-1's role in chromatin remodeling and global gene expression

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• MM Patients

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: NCT05858203
• Other Study ID Numbers: RS1442/20
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: Mar 1, 2023

• 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 May 15, 2023