Background
Study objectives
-
To provide epidemiology data on MM (incidence, temporal trends, geographical and social disparities, risk factors).
-
To provide real life data on therapeutic landscape of MM patients (nature of treatments, duration of response to each sequential line of treatment).
-
To understand the biological mechanisms associated with drug resistance and clonal evolution in MM.
-
To identify new therapeutic targets for the MM treatment.
-
To determine the impact of MM therapies on patient quality of life.
-
To provide prognostic scores predicting response to MM therapies.
-
To conduct pharmaco-economic evaluations of MM therapies.
-
To provide a large bone marrow and blood samples biocollection obtained from MM patients at subsequent disease period (diagnosis, reponse to treatment, disease progression).
Design
Study design
Study population
Study visits
Collected data | Baseline | Follow up | Disease progression | ||
---|---|---|---|---|---|
Sociodemographic | Age | x | |||
Sex | x | ||||
Profession | x | ||||
Place of residence | x | ||||
Smoking and alcohol habits | x | ||||
Hematological Family history | x | ||||
Clinical data | Medical family history | x | x | x | |
Date of diagnosis | x | x | x | ||
Anemia | x | x | x | ||
Renal failure | x | x | x | ||
Hypercalcemia | x | x | x | ||
Bone lesion | x | x | x | ||
Extramedullary disease | x | x | x | ||
Quality of life | SF-36 score | x | x | x | |
EQ-5D | x | x | x | ||
Biological data | blood | Blood count | x | x | x |
Creatinine level | x | x | x | ||
Calcemia | x | x | x | ||
LDH level | x | x | x | ||
Albuminemia | x | x | x | ||
Monoclonal protein amount | x | x | x | ||
urine | Monoclonal protein amount | x | x | x | |
Albuminuria | x | x | x | ||
Bone marrow | Flow cytometry | x | x | ||
Cytogenetic {t(11;14), t(4;14), del17p, 1p deletion, 1q gain}. | x | x | |||
ISS R-ISS | x | x | |||
Imaging | Standard radiography | x | x | ||
CT scan | x | x | |||
MRI scan | x | x | |||
PET scan | x | x | |||
Therapy | Previous lines | x | x | ||
Best response to therapy | x | x | x | ||
Duration of response | x | x | x | ||
Biocollection | BM tumor cells | x | x | ||
Blood tumor cells | x | x |