Clinical trial NCT03807128: MYeloma Resistance And Clonal Evolution
Official title: MYeloma Resistance And Clonal Evolution
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Myeloma
Cohort
Resistance
Quality of life
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population corresponds to multiple myeloma patients managed in the hematology departments of the University Hospital of Nantes and the CHD of La Roche sur Yon.

Recruitment of the hematology departments of the University Hospital of Nantes and CHD of La Roche sur Yon makes it possible to envisage an annual recruitment of 60 new myeloma diagnoses, and an annual number of 80 relapses. These data are estimated from the number of files submitted to the Multidisciplinary Collaborative Meeting (RPN) and the annual inclusion number in clinical trials. This number represents a cohort of about 140 inclusions per year. The average number of visits can be estimated at 1.5 / year per patient.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Minor patient
* Patient under guardianship
* Protected patient

Primary outcomes:
measure: Describe the mechanisms of resistance of myeloma cells.
timeFrame: Ten years
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: La Roche sur Yon Hospital Departmental
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Cyrille TOUZEAU, PU
role: PRINCIPAL_INVESTIGATOR
References: