Trials / Recruiting
RecruitingNCT03807128
MYeloma Resistance And Clonal Evolution
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,400 (estimated)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Prélèvement sanguin (2*4mL) ou médullaire (2mL) | Additional blood (2\*4mL) or bone marrow (2mL) sample depending on clinical presentation of disease |
| OTHER | Data collection through questionnaires | Collection of quality of life and occupational exposure data via questionnaires |
Timeline
- Start date
- 2019-02-11
- Primary completion
- 2034-02-11
- Completion
- 2049-02-11
- First posted
- 2019-01-16
- Last updated
- 2025-07-14
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03807128. Inclusion in this directory is not an endorsement.