Clinical trial · Observational
Optical Genome Mapping in Characterization of Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone Marrow samples collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validate the use of Optical Genome Mapping in Multiple Myeloma characterization
- timeFrame
- At MM diagnosis
- description
- Concordance scores for abnormalities detected with Optical Genome Mapping and Fluorescence In Situ Hybridization (FISH)
Secondary outcomes (1)
- measure
- Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma
- timeFrame
- At MM diagnosis
- description
- Numbers of genetic abnormalities that are detected with Optical Genome Mapping but not detected with FISH
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRajkumar 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. PMID 25439696