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

Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Genetic: DNA sequencing

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Charles DUMONTET, Pr; Phone Number: +33 04 78 46 83 40; Email: charles.dumontet@chu-lyon.fr

Study Locations

• France
  • Pierre Benite, France, 69495
    • Hospices civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• diagnosis of multiple myeloma
• availability of abnormal plasmocytes

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: multiple myeloma; mutations; genetic predisposition; sporadic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 69HCL21_0492

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No