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NCT Number: NCT03807128

MYeloma Resistance And Clonal Evolution

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

La Roche sur Yon Hospital Departmental, La Roche-sur-Yon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Data collection through questionnaires

Other

Collection of quality of life and occupational exposure data via questionnaires

Primary outcomes

  1. Describe the mechanisms of resistance of myeloma cells.

    Time frame: 15 years

    Number of resistance.

Study contacts

Contact information is provided by the study sponsor or research team.

Cyrille TOUZEAU, PU

CONTACT

[email protected]

02 40 08 32 71

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: MYRACLE

Important dates

Study start
2019
Primary completion
2034
Study completion
2049
First posted
Jan 16, 2019
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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