Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.
- Conditions
- Smoldering Multiple Myeloma
- Interventions
- Procedure: Myelogram
- Registration Number
- NCT04144387
- Lead Sponsor
- Intergroupe Francophone du Myelome
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 395
-
Age ≥ 18 years.
-
SMM defined by IMWG 2014 criteria
- 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%
- 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.
-
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:
- 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)
- Renal insufficiency: creatinine clearance <40 mL/min or serum creatinine >177 μmol/L (>20 mg/L)
- Anaemia: haemoglobin value of >2 g/dL below the lower limit of normal, or a haemoglobin value <10 g/dL
- 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:
- Clonal bone marrow plasmocytosis ≥60%
- Involved/uninvolved serum Free Light Chain (FLC) ratio ≥ 100 (The involved free light chain must be ≥100 mg/L)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test group Myelogram Each patient included in the study will be followed for 5 years
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method Assess the risk of progression to MM evaluating biological factors 5 years * 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%Assess the risk of progression to MM evaluating radiological markers 5 years 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 bonesDescribe the clonal and sub-clonal evolution of SMM 5 years 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).
Describe annual risk of progression from SMM to MM at 5 years 5 years
Trial Locations
- Locations (84)
CHU UCL Namur ASBL Site Godinne
🇧🇪Yvoir, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Centre hospitalier de la Côte Basque
🇫🇷Bayonne, France
Institut Jules Bordet
🇧🇪Bruxelles, Belgium
CHU Amiens Sud
🇫🇷Amiens, France
Centre Hospitalier
🇫🇷Valenciennes, France
Ch Annecy Genevois
🇫🇷Annecy, France
CHRU - Hôpital du Bocage
🇫🇷Angers, France
Centre Hospitalier d'Argenteuil Victor Dupouy
🇫🇷Argenteuil, France
CH d'Arras
🇫🇷Arras, France
Centre Hospitalier de Auch
🇫🇷Auch, France
Hôpital Avicenne
🇫🇷Bobigny, France
Centre Hospitalier H. Duffaut
🇫🇷Avignon, France
Hôpital Nord Franche Comté
🇫🇷Belfort, France
Institut Bergonié - Pavillon Saint Genès - 1er étage
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Médipôle de Savoie
🇫🇷Challes-les-Eaux, France
CHU Caen - Côte de Nacre
🇫🇷Caen, France
Centre Hospitalier William Morey
🇫🇷Chalon-sur-Saône, France
CH Chambéry
🇫🇷Chambéry, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
CHU François Mitterand
🇫🇷Dijon, France
CHU de Grenoble
🇫🇷Grenoble, France
Centre Hospitalier de Dunkerque
🇫🇷Dunkerque, France
Hôpital de Fréjus
🇫🇷Fréjus, France
Institut Daniel Hollard
🇫🇷Grenoble, France
Hospital Jacques Monod
🇫🇷Le Havre, France
Centre hospitalier Robert Boulin
🇫🇷Libourne, France
CHRU Hôtel Dieu
🇫🇷Nantes, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint-Priest, France
Hôpital Archet 1
🇫🇷Nice, France
CH La Source
🇫🇷Orléans, France
CH Roubaix
🇫🇷Roubaix, France
Centre Hospitalier Simone Veil
🇫🇷Blois, France
CHRU Brest - Hôpital A. Morvan
🇫🇷Brest, France
Centre hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
CH René Dubos
🇫🇷Cergy Pontoise, France
Hôpital d'Instruction des Armées Percy
🇫🇷Clamart, France
CHU Henri Mondor
🇫🇷Créteil, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
Groupe Hospitalier de La Rochelle
🇫🇷La Rochelle, France
Centre Hospitalier Universitaire (CHU) de Limoges
🇫🇷Limoges, France
CHRU Hôpital Claude Huriez
🇫🇷Lille, France
Centre Hospitalier Lyon Sud
🇫🇷Lyon, France
Hôpital du Scorff
🇫🇷Lorient, France
Centre Léon Bérard
🇫🇷Lyon, France
CH Meaux
🇫🇷Meaux, France
Hôpital de Mercy (CHR Metz-Thionville)
🇫🇷Metz, France
Hospital Sainte Blandine
🇫🇷Metz, France
Clinique du Parc
🇫🇷Montpellier, France
CHRU Hôpitaux de Brabois
🇫🇷Nancy, France
Centre de Recherche Clinique / GHT des Landes
🇫🇷Mont-de-Marsan, France
Hopital Saint Eloi - CHU Montpellier
🇫🇷Montpellier, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Hôpital E. Muller
🇫🇷Mulhouse, France
CHU Carémeau, Institut de Cancérologie du Guard
🇫🇷Nîmes, France
CHU Hôpital Saint Antoine
🇫🇷Paris, France
CH Saint Jean
🇫🇷Perpignan, France
Hôpital Necker
🇫🇷Paris, France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
🇫🇷Pessac, France
Hôpital Saint Louis
🇫🇷Paris, France
CHRU Hôpital de Pontchaillou
🇫🇷Rennes, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Privé Sévigné
🇫🇷Rennes, France
La Pitié
🇫🇷Paris, France
CHU Poitiers - Pôle régional de Cancérologie
🇫🇷Poitiers, France
Centre Hospitalier de Perigueux
🇫🇷Périgueux, France
Centre Hospitalier de Quimper Cornouaille
🇫🇷Quimper, France
Hôpital Robert Debré
🇫🇷Reims, France
Centre Hospitalier Jacques Puel
🇫🇷Rodez, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Hospitalier Yves Le Foll
🇫🇷Saint-Brieuc, France
CH Saint Malo
🇫🇷Saint-Malo, France
Centre hospitalier de Tarbes
🇫🇷Tarbes, France
Strasbourg Oncologie Libérale
🇫🇷Strasbourg, France
CHU Strasbourg - Hôpital de Hautepierre
🇫🇷Strasbourg, France
Hôpital Inter-Armées Ste Anne
🇫🇷Toulon, France
Pôle IUCT Oncopole CHU
🇫🇷Toulouse, France
Centre Hospitalier de Valence
🇫🇷Valence, France
CHRU Hôpital Bretonneau - Centre Henry Kaplan
🇫🇷Tours, France
Centre Hospitalier de Troyes
🇫🇷Troyes, France
CH Bretagne Atlantique Vannes et Auray - P. Chubert
🇫🇷Vannes, France
Centre Hospitalier Princesse Grace
🇲🇨Monaco, Monaco
CHV André Mignot - Université de Versailles
🇫🇷Versailles, France