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NCT05331313 Clinical Trial

The Aim is to Identify Recurrent Genomic Mutations and/or Predisposing Polymorphisms in Patients With Sporadic Cases of Multiple Myeloma

Multiple Myeloma Clinical Trial

— MMSPORADGEN  

Official title:
Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05331313
Other study ID # 69HCL21_0492
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date August 31, 2024

Study information
Verified date March 2022
Source Hospices Civils de Lyon
Contact Charles DUMONTET, Pr
Phone 04 78 46 83 40
Email charles.dumontet@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. In this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. Plasmocytes will be obtained by immunomagnetic enrichment using CD138+ beads.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date August 31, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - diagnosis of multiple myeloma - availability of abnormal plasmocytes Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA sequencing
The aim of this study is to perform DNA sequencing on abnormal plasmocytes obtained from patients with multiple myeloma, in order to identify alterations which are associated with the existence of this disease. DNA analyses will be performed in a single experiment once all samples have been collected.

Locations
Country Name City State
France Hospices Civils de Lyon Pierre Benite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary DNA mutations associated with the existence of multiple myeloma DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases. baseline, pre-intervention/procedure/surgery
Primary DNA mutations associated with the existence of multiple myeloma DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases. during the intervention/procedure/surgery
Primary DNA mutations associated with the existence of multiple myeloma DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases. immediately after the intervention/procedure/surgery
Primary DNA mutations associated with the existence of multiple myeloma DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases. at 1 year
Primary DNA mutations associated with the existence of multiple myeloma DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases. up to 24 weeks
Primary DNA mutations associated with the existence of multiple myeloma DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases. through study completion, an average of 1 year
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