Multiple MyelomaOMYFINNCT06552221
Finistere Myeloma Observatory (OMYFIN)
An observational study of Multiple Myeloma, run by University Hospital, Brest at 1 site in France.
Trial summary
Current molecular risk stratification of multiple myeloma (MM), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive symptomatic multiple myeloma patients seen and treated i Hematology Department at Brest University Hospital from January 1, 2012 whose CKS1B/CDKN2C copy number ratio at diagnosis is calculable.
Who may be able to join
- Age at or over 18 years
- Symptomatic multiple myeloma
- Informed consent given
- FISH-based cytogenetic results obtained
Who cannot join
- Age under 18 years
- MGUS or SMM
- No informed consent
- No FISH-based cytogenetic results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finistere Myeloma Observatory: Retrospective Study of Chromosome 1 Abnormalities and Prognostic Value of a CKS1B (on 1q21)/CDKN2C (on 1p32) Copy Number Ratio in Myeloma.
Current molecular risk stratification of multiple myeloma (MM), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. About 30% of genetic events map to chromosome 1 : most upregulated genes to 1q and most downregulated ones to 1p. CKS1B gains on 1q21 and CDKN2C loss on 1p32, both favoring cell cycle progression, portended impaired outcome in many but not all studies. Based on their recurrence and considering their functional convergence, we hypothesized CKS1B/CDKN2C copy number ratio to be a risk factor fitter than each aberration alone.
Read the detailed description
This single-center retrospective study, is designed to enroll all consecutive newly diagnosed adult patients aged ≥18 years, transplant-eligible and not. All patients are routinely tested for CKS1B and CDKN2C and treated according to consensus guidelines. Data are being collected from 2012. For each subject, we calculate a FISH-based ratio by CKS1B on CDKN2C copy number : it is equal to 1 with no change in copy number and >1 in case of CKS1B gains, CDKN2C loss or both. In patients with CDKN2C biallelic loss, the ratio is not equal to 0, but to CKS1B copy number, as functional consequence should prevail over arithmetic result. We will, then, analyze separately the impact of CKS1B gains, CDKN2C loss and CKS1B/CDKN2C ratio on PFS and OS.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on response rate
Measured: 10 years
Secondary outcomes (1)
Progression-free survival (PFS)
The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on PFS
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2012
- Primary completion15 Dec 2022
- Study completion30 Jun 2023
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.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Richard Eveillard, MD, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552221
- Sponsor's protocol ID
- OMYFIN (29BRC20.0178)
- Acronym
- OMYFIN
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finistere Myeloma Observatory: Retrospective Study of Chromosome 1 Abnormalities and Prognostic Value of a CKS1B (on 1q21)/CDKN2C (on 1p32) Copy Number Ratio in Myeloma.
- ClinicalTrials.gov ID
- NCT06552221
- Acronym / sponsor ID
- OMYFIN / OMYFIN (29BRC20.0178)
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Aug 2024 (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.
Current molecular risk stratification of multiple myeloma (MM), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. About 30% of genetic events map to chromosome 1 : most upregulated genes to 1q and most downregulated ones to 1p. CKS1B gains on 1q21 and CDKN2C loss on 1p32, both favoring cell cycle progression, portended impaired outcome in many but not all studies. Based on their recurrence and considering their functional convergence, we hypothesized CKS1B/CDKN2C copy number ratio to be a risk factor fitter than each aberration alone.
Detailed description
This single-center retrospective study, is designed to enroll all consecutive newly diagnosed adult patients aged ≥18 years, transplant-eligible and not. All patients are routinely tested for CKS1B and CDKN2C and treated according to consensus guidelines. Data are being collected from 2012. For each subject, we calculate a FISH-based ratio by CKS1B on CDKN2C copy number : it is equal to 1 with no change in copy number and >1 in case of CKS1B gains, CDKN2C loss or both. In patients with CDKN2C biallelic loss, the ratio is not equal to 0, but to CKS1B copy number, as functional consequence should prevail over arithmetic result. We will, then, analyze separately the impact of CKS1B gains, CDKN2C loss and CKS1B/CDKN2C ratio on PFS and OS.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive symptomatic multiple myeloma patients seen and treated i Hematology Department at Brest University Hospital from January 1, 2012 whose CKS1B/CDKN2C copy number ratio at diagnosis is calculable.
Key inclusion criteria (4 listed)
- Age at or over 18 years
- Symptomatic multiple myeloma
- Informed consent given
- FISH-based cytogenetic results obtained
Key exclusion criteria (4 listed)
- Age under 18 years
- MGUS or SMM
- No informed consent
- No FISH-based cytogenetic results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response rate
Time frame: 10 years
The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on response rate
1 secondary outcome
Progression-free survival (PFS)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
Jean-Richard Eveillard, MD principal investigator
CHU de Brest
1 site 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 University Hospital, Brest at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 10 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 13 Aug 2024.