Multiple MyelomaTEDROMMNCT05888636
Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma
An observational study of Multiple Myeloma, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial 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%). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ChIP-seq, NGS, ATAC-seq
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Jun 2019to 31 Dec 2024
- How long will I take part?
- 12 Months
- 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: For the study, samples from patients with MGUS, MM smouldering and syntomatic MM will be used
Who may be able to join
- Compare Transcriptomics and epigenetic profile
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
Maurizio Fanciulli, PhD, 06-52662800, maurizio.fanciulli@ifo.it
About this study
Official title: Transcriptomics and Epigenetics Analysis for Biomarkers Identification Involved in Drug-resistance Mechanisms of Multiple Myeloma
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
- Being tested
- ChIP-seq, NGS, ATAC-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.
ChIP-seq, NGS, ATAC-seqOther
Bone narrow sampling
| Study group | Role | What they receive |
|---|---|---|
| MGUS | Not described Receives: Other: ChIP-seq, NGS, ATAC-seq | |
| MM smouldering | Not described Receives: Other: ChIP-seq, NGS, ATAC-seq | |
| Syntomatic MM | Not described Receives: Other: ChIP-seq, NGS, ATAC-seq |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start18 Jun 2019
- Primary completion11 Nov 2023
- Study completion31 Dec 2024 (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
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, University of Rome Tor Vergata, S.Eugenio Hospital
- Responsible party
- Sponsor
- Investigators
- Maurizio Fanciulli, PhD, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888636
- Sponsor's protocol ID
- RS1237
- Acronym
- TEDROMM
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomics and Epigenetics Analysis for Biomarkers Identification Involved in Drug-resistance Mechanisms of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05888636
- Acronym / sponsor ID
- TEDROMM / RS1237
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, University of Rome Tor Vergata, S.Eugenio Hospital
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jun 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MGUS | – | Other: ChIP-seq, NGS, ATAC-seq |
| MM smouldering | – | Other: ChIP-seq, NGS, ATAC-seq |
| Syntomatic MM | – | Other: ChIP-seq, NGS, ATAC-seq |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the study, samples from patients with MGUS, MM smouldering and syntomatic MM will be used
Key inclusion criteria (1 listed)
- Compare Transcriptomics and epigenetic profile
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 |
|---|---|---|
| ChIP-seq, NGS, ATAC-seqBone narrow sampling | Other | MGUS, MM smouldering, Syntomatic MM |
Primary outcome
Transcriptomics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples
Time frame: 12 months
Characterize genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement.
Epigenetics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples
Time frame: 12 months
Quantify genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Maurizio Fanciulli, PhD principal investigator
IRCCS "Regina Elena" National Cancer Institute
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 22 Mar 2024. 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?
Transcriptomics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples (time frame: 12 months). The study lists 2 primary outcomes in all. 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 22 Mar 2024.