Optical Genome Mapping in Characterization of Multiple Myeloma

Multiple Myeloma Clinical Trial

— MYELOPTIC  

Official title:

Optical Genome Mapping in Characterization of Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786105
• Other study ID #: 2022-014
• Secondary ID: 2022-A02286-37
• Status: Completed
• Start date: April 21, 2023
• Est. completion date: November 21, 2023

Study information

• Verified date: March 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Bone Marrow samples collection
Bone Marrow samples collection - one ethylenediaminetetraacetic acid (EDTA) tube - for Optical Genome Mapping

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (3)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	GENTYANE (GEnoTYpage and sequencing in AuvergNE), Hôpitaux Universitaires de Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (1)

Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate the use of Optical Genome Mapping in Multiple Myeloma characterization	Concordance scores for abnormalities detected with Optical Genome Mapping and Fluorescence In Situ Hybridization (FISH)	At MM diagnosis
Secondary	Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma	Numbers of genetic abnormalities that are detected with Optical Genome Mapping but not detected with FISH	At MM diagnosis