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Finistere Myeloma Observatory (OMYFIN)

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06552221
Acronym
OMYFIN
Enrollment
300
Registered
2024-08-13
Start date
2012-01-01
Completion date
2023-06-30
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age at or over 18 years * Symptomatic multiple myeloma * Informed consent given * FISH-based cytogenetic results obtained

Exclusion criteria

* Age under 18 years * MGUS or SMM * No informed consent * No FISH-based cytogenetic results

Design outcomes

Primary

MeasureTime frameDescription
Response rate10 yearsThe aim is to assess the impact of CKS1B/CDKN2C copy number ratio on response rate

Secondary

MeasureTime frameDescription
Progression-free survival (PFS)10 yearsThe aim is to assess the impact of CKS1B/CDKN2C copy number ratio on PFS

Other

MeasureTime frameDescription
Overall survival (OS)10 yearsThe aim is to assess the impact of CKS1B/CDKN2C copy number ratio on OS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026