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NCT Number: NCT06552221

Finistere Myeloma Observatory (OMYFIN)

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response rate

    Time frame: 10 years

    The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on response rate

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 10 years

    The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on PFS

Other outcomes

  1. Overall survival (OS)

    Time frame: 10 years

    The aim is to assess the impact of CKS1B/CDKN2C copy number ratio on OS

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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.

Acronym: OMYFIN

Important dates

Study start
2012
Primary completion
2022
Study completion
2023
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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