MYeloma Resistance And Clonal Evolution

NCT ID: NCT03807128

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-11

Study Completion Date

2049-02-11

Brief Summary

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Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

Detailed Description

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The MYRACLE cohort study aims at including all patients (\>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MYRACLE patients

Prélèvement sanguin (2*4mL) ou médullaire (2mL)

Intervention Type OTHER

Additional blood (2\*4mL) or bone marrow (2mL) sample depending on clinical presentation of disease

Data collection through questionnaires

Intervention Type OTHER

Collection of quality of life and occupational exposure data via questionnaires

Interventions

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Prélèvement sanguin (2*4mL) ou médullaire (2mL)

Additional blood (2\*4mL) or bone marrow (2mL) sample depending on clinical presentation of disease

Intervention Type OTHER

Data collection through questionnaires

Collection of quality of life and occupational exposure data via questionnaires

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient consulting due to the discovery or recurrence of MM according to international diagnostic criteria (IMWG 2014)
* Patient having consented to participate in the study and his/her biocollection
* Patient affiliated to or benefiting from a social security scheme or similar

Exclusion Criteria

* Minors
* Major under guardianship or curatorship
* Protected persons.
* Pregnant or breast-feeding women
* Persons benefiting from the AME
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cyrille TOUZEAU, PU

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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La Roche sur Yon Hospital Departmental

La Roche-sur-Yon, , France

Site Status RECRUITING

Nantes University Hospital

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cyrille TOUZEAU, PU

Role: CONTACT

02 40 08 32 71

Facility Contacts

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Cyrille TOUZEAU, PU

Role: primary

02 53 48 24 05

References

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Derrien J, Gastineau S, Frigout A, Giordano N, Cherkaoui M, Gaborit V, Boinon R, Douillard E, Devic M, Magrangeas F, Moreau P, Minvielle S, Touzeau C, Letouze E. Acquired resistance to a GPRC5D-directed T-cell engager in multiple myeloma is mediated by genetic or epigenetic target inactivation. Nat Cancer. 2023 Nov;4(11):1536-1543. doi: 10.1038/s43018-023-00625-9. Epub 2023 Aug 31.

Reference Type DERIVED
PMID: 37653140 (View on PubMed)

Other Identifiers

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IDRCB - ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

RC18_0197

Identifier Type: -

Identifier Source: org_study_id

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