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

NCT05331313 | Unknown

• 1 other identifier: 69HCL21_0492
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

genetic predisposition; mutations; sporadic; multiple myeloma

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

DNA sequencing GENETIC

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.

patients with a diagnosis of multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient samples will be accrued from Intergroupe Francophone du Myélome (IFM) centers in France, in the context of primary care clinics. The investigators aim to collect up to 1,000 samples.

You may qualify if:

• diagnosis of multiple myeloma
• availability of abnormal plasmocytes

You may not qualify if:

• \- none

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA analyses will be performed on purified abnormal plasmocytes, obtained from bone marrow aspirates performed during the standard follow-up of patients with multiple myeloma.

MeSH Terms

Conditions

Multiple Myeloma; Genetic Predisposition to Disease

Interventions

Sequence Analysis, DNA

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Central Study Contacts

Charles DUMONTET, Pr

CONTACT

04 78 46 83 40; charles.dumontet@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 15, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: August 31, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-03

Locations

FR (1)