NCT06552221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

11 years

First QC Date

August 9, 2024

Last Update Submit

August 9, 2024

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Response rate

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

    10 years

Secondary Outcomes (1)

  • Progression-free survival (PFS)

    10 years

Other Outcomes (1)

  • Overall survival (OS)

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jean-Richard Eveillard, MD

    CHU de Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

January 1, 2012

Primary Completion

December 15, 2022

Study Completion

June 30, 2023

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

FR(1)