MYELOPTIC: Optical Genome Mapping in Characterization of Multiple Myeloma

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786105

Collaborator

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

Enrollment

Location

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: Bone Marrow samples collection

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 Design

Study Type:

Observational

Anticipated Enrollment :

8 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Optical Genome Mapping in Characterization of Multiple Myeloma

Anticipated Study Start Date :

Mar 21, 2023

Anticipated Primary Completion Date :

Mar 21, 2028

Anticipated Study Completion Date :

Mar 21, 2028

Outcome Measures

Primary Outcome Measures

Validate the use of Optical Genome Mapping in Multiple Myeloma characterization [At MM diagnosis]
Concordance scores for abnormalities detected with Optical Genome Mapping and Fluorescence In Situ Hybridization (FISH)

Secondary Outcome Measures

Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma [At MM diagnosis]
Numbers of genetic abnormalities that are detected with Optical Genome Mapping but not detected with FISH

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de cancérologie Strasbourg Europe	Strasbourg		France	67033

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Institut de cancérologie Strasbourg Europe

ClinicalTrials.gov Identifier:

NCT05786105

Other Study ID Numbers:

2022-014
2022-A02286-37

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Mar 27, 2023