MYeloma Resistance And Clonal Evolution
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prélèvement sanguin (2*4mL) ou médullaire (2mL), Data collection through questionnaires.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Describe the mechanisms of resistance of myeloma cells. [Time frame: 15 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- La Roche sur Yon Hospital Departmental — La Roche-sur-Yon
- Nantes University Hospital — Nantes
Publications
- 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. PMID 37653140
Identifiers
NCT: NCT03807128 · RC18_0197 · IDRCB - ANSM