This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.
In 2014, the International Myeloma Working Group (IMWG) proposed a revised classification of multiple myeloma (MM) and smoldering myeloma (SMM). Since the new definition of SMM proposed excludes "ultra-high risk SMM", the evolution profile of SMM will change. Therefore, investigators need to update their knowledge of SMM to optimize the management of patients. This project is expected to describe more precisely the new landscape of SMM. The results will help to establish new recommendations for the standard care of SMM and especially for defining accurate follow-up and risk stratifying.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
395
Two additional myelograms will be performed comparing to standard of care.
Assess the annual risk estimated at 2 years of progression from SMM to MM
Progression to MM will be defined, according to IMWG 2014 revised classification, by the apparition of one or more myeloma defining events: * Evidence of end organ damage that can be attributed to the underlying MM (CRAB criteria) * Presence of one of the following biomarkers of malignancy (new criteria of MM introduced in 2014 IMWG recommendations)
Time frame: 2 years
Assess the risk of progression to MM evaluating biological factors
* Progression of monoclonal component level (serum M component, urine M component or FLC involved/uninvolved) defined by increase of ≥ 25% from inclusion value. * Progression of percentage of phenotypically abnormal Bone Marrow Plasma Cells defined by increase of ≥ 10 % from inclusion value or an increase to over 95%
Time frame: 5 years
Assess the risk of progression to MM evaluating radiological markers
MRI progression : Progression of MRI abnormalities defined by any one or more of the following * Appearance of new focal lesion or new diffuse infiltration of previously unaffected regions * Growth of previously preexisting \< 5mm focal(s) lesion(s) * Progressive diffuse infiltration of already affected bones
Time frame: 5 years
Describe the clonal and sub-clonal evolution of SMM
Genetic analysis of bone marrow plasma cells at inclusion and during follow up to give data about the clonal and subclonal evolution of SMM (analysis of the mutations present in the tumor plasma cells, the allele frequency of each mutations, the determination of the clonal evolution mode for patients who will evolve to overt MM, the evaluation of copy number changes enabling to detect all the prognostic changes (1p32, 1q, 17p13), and (v) all the 14q32 translocations).
Time frame: 5 years
Describe annual risk of progression from SMM to MM at 5 years
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Cliniques Universitaires Saint-Luc
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
CHU UCL Namur ASBL Site Godinne
Yvoir, Belgium
Centre Hospitalier
Abbeville, France
CHU Amiens Sud
Amiens, France
CHRU - Hôpital du Bocage
Angers, France
Ch Annecy Genevois
Annecy, France
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil, France
CH d'Arras
Arras, France
Centre Hospitalier de Auch
Auch, France
...and 80 more locations
Time frame: 5 years