NCT05786105

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 15, 2023

Last Update Submit

March 12, 2024

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluate Optical Genome Mapping for identification of genetic abnormalities that are not detected with FISH in Multiple Myeloma

    At MM diagnosis

Interventions

Bone Marrow samples collectionOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

Related 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.

    PMID: 25439696BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 27, 2023

Study Start

April 21, 2023

Primary Completion

November 21, 2023

Study Completion

November 21, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

FR(1)