Optical Genome Mapping in Characterization of Multiple Myeloma (MYELOPTIC)

March 12, 2024 updated by: Institut de cancérologie Strasbourg Europe
The current cytogenetic characterization of Multiple Myeloma (including chromosome and gene abnormalities identification in abnormal plasma cells) encounters some limitations. Indeed current techniques only enable to analyze a limited numbers of predefined abnormalities. New tools that will allow for characterization of abnormalities involved in multiple myeloma development are thus required. The interest of Optical Genome Mapping has already been demonstrated in other hematological diseases. The present study aims at validating Optical Genome Mapping in genetic abnormalities identification for patients with Multiple Myeloma (MM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this study, supplementary samples will be collected during bone marrow biopsy performed at MM diagnosis. These will be used for CD138+ Plasma Cell Isolation and sent to GENTYANE (GEnoTYpage and sequencing in AuvergNE) platform in Clermont-Ferrand for Optical Genome Mapping.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67033
        • Institut de cancérologie Strasbourg Europe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with a diagnosis of multiple myeloma not previously treated (except with corticosteroids) and requiring treatment initiation (presence of CRAB criteria).

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Non previously treated Multiple Myeloma (criteria from the International Myeloma Working Group)
  • Presence of CRAB criteria (Calcium Renal Anemia Bone : Calcemia > 2.75 mmol/l or > 0.25 mmol/l higher than the Upper Limit of Normal ; serum creatinine > 173 μmol/l or creatinine clearance < 40ml per minute attributed to myeloma ; anemia with hemoglobin value < 10g/dl or more than 2g/dl below the Lower Limit of Normal, bone lesions with osteolytic lesions or osteoporotic vertebral collapses attributed to myeloma)

Exclusion Criteria:

  • Opposition of the patient
  • Failure of myelogram
  • Previous treatment of multiple myeloma (except with corticosteroids)
  • Failure of FISH
  • Minor or patients placed under guardianship or supervision
  • Patients deprived of liberty
  • Patients placed under judicial protection
  • Patients that are not able to express their consent
  • Pregnant and breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate the use of Optical Genome Mapping in Multiple Myeloma characterization
Time Frame: At MM diagnosis
Concordance scores for abnormalities detected with Optical Genome Mapping and Fluorescence In Situ Hybridization (FISH)
At MM diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma
Time Frame: At MM diagnosis
Numbers of genetic abnormalities that are detected with Optical Genome Mapping but not detected with FISH
At MM diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

Hôpitaux Universitaires de Strasbourg
GENTYANE (GEnoTYpage and sequencing in AuvergNE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Actual)

November 21, 2023

Study Completion (Actual)

November 21, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-014
  • 2022-A02286-37 (Other Identifier: ID-RCB Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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