Multiple MyelomaAATF/Che-1NCT05858203
Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment
An observational study of Multiple Myeloma, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ATAC-seq and ChIP-seq
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Dec 2020to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MM Patients
Who may be able to join
- MM Patients
Who cannot join
- No exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Active, not recruiting
Regina elena Cancer Institute
Roma, 00144
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
About this study
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
- Conditions
- Multiple Myeloma
- Being tested
- ATAC-seq and ChIP-seq
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATAC-seq and ChIP-seqOther
CD138+ cells will be isolated from the bone marrow of MM patients and will be subjected to ATAC-seq and ChIP-seq analyses, by useing specific antibodies, to better understand the involvment of Che-1 in MM tumorogenesis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Che-1 involvement in MM tumorigenesis
Characterization of Che-1's role in chromatin remodeling and global gene expression
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start22 Dec 2020
- Primary completion21 Mar 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858203
- Sponsor's protocol ID
- RS1442/20
- Acronym
- AATF/Che-1
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment
- ClinicalTrials.gov ID
- NCT05858203
- Acronym / sponsor ID
- AATF/Che-1 / RS1442/20
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MM Patients
Key inclusion criteria (1 listed)
- MM Patients
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATAC-seq and ChIP-seqCD138+ cells will be isolated from the bone marrow of MM patients and will be subjected to ATAC-seq and ChIP-seq analyses, by useing specific antibodies, to better understand the involvment of Che-1 in MM tumorogenesis. | Other | – |
Primary outcome
Che-1 involvement in MM tumorigenesis
Time frame: About 2 years
Characterization of Che-1's role in chromatin remodeling and global gene expression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Regina Elena Cancer Institute at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurizio fanciulli, PhD (+39 06 52662800, maurizio.fanciulli@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Che-1 involvement in MM tumorigenesis (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.