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

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ClinicalTrials.gov Identifier: NCT05331313
Recruitment Status : Not yet recruiting
First Posted : April 15, 2022
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
Multiple Myeloma Genetic: DNA sequencing

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. DNA mutations associated with the existence of multiple myeloma [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • diagnosis of multiple myeloma
  • availability of abnormal plasmocytes

Exclusion Criteria:

- none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05331313


Contacts
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Contact: Charles DUMONTET, Pr 04 78 46 83 40 ext +33 charles.dumontet@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon
Pierre Benite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05331313    
Other Study ID Numbers: 69HCL21_0492
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: March 2022

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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:
genetic predisposition
mutations
sporadic
multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases