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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05331313
Collaborator
(none)
1,000
1
21
47.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: DNA sequencing

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
patients with a diagnosis of multiple myeloma

This study will involve a single patient group, namely patients with a diagnosis of multiple myeloma diagnosed by a bone marrow aspirate with cytological analysis of the bone marrow smear.Bone marrow samples obtained during the routine follow-up will undergo plasmocyte enrichment using immunopurification using CD138+ beads and nucleic acids will be extracted for sequencing.

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.

Outcome Measures

Primary Outcome Measures

  1. DNA mutations associated with the existence of multiple myeloma [baseline, pre-intervention/procedure/surgery]

    DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.

  2. DNA mutations associated with the existence of multiple myeloma [during the intervention/procedure/surgery]

    DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.

  3. DNA mutations associated with the existence of multiple myeloma [immediately after the intervention/procedure/surgery]

    DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.

  4. DNA mutations associated with the existence of multiple myeloma [at 1 year]

    DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.

  5. DNA mutations associated with the existence of multiple myeloma [up to 24 weeks]

    DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.

  6. DNA mutations associated with the existence of multiple myeloma [through study completion, an average of 1 year]

    DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • diagnosis of multiple myeloma

  • availability of abnormal plasmocytes

Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Pierre Benite France 69495

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05331313
Other Study ID Numbers:
  • 69HCL21_0492
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022