MYeloma Resistance And Clonal Evolution

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT03807128
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Start: 2019-02-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06
• Primary Completion: 2029-02-11
• Study Completion: 2029-02-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• Patient with diagnosis of multiple myeloma according to standard criteria
• Age >18

Exclusion Criteria

• Minor patient
• Patient under guardianship
• Protected patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the mechanisms of resistance of myeloma cells.	Ten years	Number of resistance.

Trial Locations

Locations (2)

La Roche sur Yon Hospital Departmental; 🇫🇷 La Roche-sur-Yon, France

Nantes University Hospital; 🇫🇷 Nantes, France