MYeloma Resistance And Clonal Evolution (MYRACLE)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Other: Data collection through questionnaires; Other: Prélèvement sanguin (2*4mL) ou médullaire (2mL)

Study type: Observational

Funder types: Other

Identifiers

NCT03807128

IDRCB - ANSM (Other Identifier)

RC18_0197

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,400 participants in 1 patient group

MYRACLE patients

Treatment:

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

Other: Data collection through questionnaires