Myelogram: Two additional myelograms will be performed comparing to standard of care.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years.
* SMM defined by IMWG 2014 criteria
1. Serum monoclonal protein (IgG or IgA) ≥30 g/L and/or urinary monoclonal protein ≥500 mg per 24 h and/or clonal bone marrow plasma cells 10-60%
2. Absence of myeloma defining events or amyloidosis
* Diagnosed less than 1 year before the inclusion
* Able and willing to give valid written informed consent. Patients must give written informed consent (IC) in accordance with institutional and local guidelines.
Exclusion Criteria:
* Previous antimyeloma treatment including bisphosphonates
* Second Primary Malignancy and/or auto-immune disease treated by immunosuppressive drugs.
* Evidence of end organ damage that can be attributed to the underlying SMM:
1. Hypercalcaemia: serum calcium \>0.25 mmol/L (\>10 mg/L) higher than the upper limit of normal or \>2.75 mmol/L (\>110 mg/L)
2. Renal insufficiency: creatinine clearance \<40 mL/min or serum creatinine \>177 μmol/L (\>20 mg/L)
3. Anaemia: haemoglobin value of \>2 g/dL below the lower limit of normal, or a haemoglobin value \<10 g/dL
4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or Positron Emission Tomography-Computed Tomography (PET-CT)
* Presence of one of the following biomarkers of malignancy:
1. Clonal bone marrow plasmocytosis ≥60%
2. Involved/uninvolved serum Free Light Chain (FLC) ratio ≥ 100 (The involved free light chain must be ≥100 mg/L)
3. Presence of one or more focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
* History of malignancy other than SMM within 3 years before inclusion
* Amyloidosis
* POEMS syndrome
* Contraindication to MRI
* Pregnancy
* Nursing mother
* Legally protected adults (under judicial protection, guardianship, or supervision)
Primary outcome measure(s)
Assess the annual risk estimated at 2 years of progression from SMM to MM — 2 years 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)
Trial sites (90)
Facility
City
Region
Status
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
Centre Hospitalier H. Duffaut
Avignon
France
Centre hospitalier de la Côte Basque
Bayonne
France
Hôpital Nord Franche Comté
Belfort
France
Centre Hospitalier Simone Veil
Blois
France
Hôpital Avicenne
Bobigny
France
Institut Bergonié - Pavillon Saint Genès - 1er étage
Bordeaux
France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
France
Centre hospitalier Pierre Oudot
Bourgoin
France
CHRU Brest - Hôpital A. Morvan
Brest
France
CHU Caen - Côte de Nacre
Caen
France
Centre Hospitalier
Cannes
France
CH René Dubos
Cergy-Pontoise
France
Médipôle de Savoie
Challes-les-Eaux
France
Centre Hospitalier William Morey
Chalon-sur-Saône
France
CH Chambéry
Chambéry
France
Hôpital d'Instruction des Armées Percy
Clamart
France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
France
CHU Henri Mondor
Créteil
France
Centre Hospitalier
Dax
France
CHU François Mitterand
Dijon
France
Centre Hospitalier de Dunkerque
Dunkirk
France
Hôpital de Fréjus
Fréjus
France
CHU de Grenoble
Grenoble
France
Institut Daniel Hollard
Grenoble
France
CHD Vendée
La Roche-sur-Yon
France
Groupe Hospitalier de La Rochelle
La Rochelle
France
Hospital Jacques Monod
Le Havre
France
Centre Hospitalier
Le Mans
France
Centre Hospitalier
Lens
France
Centre hospitalier Robert Boulin
Libourne
France
+ 50 more sites — see the full list on the official registry below.
More Intergroupe Francophone du Myelome trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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