Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.
NCT ID: NCT04144387
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
395 participants
INTERVENTIONAL
2020-02-11
2028-12-31
Brief Summary
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Detailed Description
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The results will help to establish new recommendations for the standard care of SMM and especially for defining accurate follow-up and risk stratifying.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Test group
Each patient included in the study will be followed for 5 years
Myelogram
Two additional myelograms will be performed comparing to standard of care.
Interventions
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Myelogram
Two additional myelograms will be performed comparing to standard of care.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Intergroupe Francophone du Myelome
NETWORK
Responsible Party
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Principal Investigators
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Pr. Olivier Decaux
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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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
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
CHRU Hôpital Claude Huriez
Lille, , France
Centre Hospitalier Universitaire (CHU) de Limoges
Limoges, , France
Hôpital du Scorff
Lorient, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Centre Léon Bérard
Lyon, , France
CH Meaux
Meaux, , France
Hospital Sainte Blandine
Metz, , France
Hôpital de Mercy (CHR Metz-Thionville)
Metz, , France
Centre de Recherche Clinique / GHT des Landes
Mont-de-Marsan, , France
Clinique du Parc
Montpellier, , France
Hopital Saint Eloi - CHU Montpellier
Montpellier, , France
Hôpital E. Muller
Mulhouse, , France
CHRU Hôpitaux de Brabois
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
CHRU Hôtel Dieu
Nantes, , France
Hôpital Archet 1
Nice, , France
CHU Carémeau, Institut de Cancérologie du Guard
Nîmes, , France
CH La Source
Orléans, , France
CHU Hôpital Saint Antoine
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Necker
Paris, , France
Hôpital Saint Louis
Paris, , France
La Pitié
Paris, , France
CH Saint Jean
Perpignan, , France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac, , France
Centre Hospitalier de Perigueux
Périgueux, , France
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, , France
Centre Hospitalier de Quimper Cornouaille
Quimper, , France
Hôpital Robert Debré
Reims, , France
CHRU Hôpital de Pontchaillou
Rennes, , France
Hôpital Privé Sévigné
Rennes, , France
Centre Hospitalier Jacques Puel
Rodez, , France
CH Roubaix
Roubaix, , France
Centre Henri Becquerel
Rouen, , France
Centre Hospitalier Yves Le Foll
Saint-Brieuc, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest, , France
Centre Hospitalier
Saint-Quentin, , France
CH Saint Malo
St-Malo, , France
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Strasbourg Oncologie Libérale
Strasbourg, , France
Centre hospitalier de Tarbes
Tarbes, , France
Hôpital Inter-Armées Ste Anne
Toulon, , France
Pôle IUCT Oncopole CHU
Toulouse, , France
CHRU Hôpital Bretonneau - Centre Henry Kaplan
Tours, , France
Centre Hospitalier de Troyes
Troyes, , France
Centre Hospitalier de Valence
Valence, , France
Centre Hospitalier
Valenciennes, , France
CH Bretagne Atlantique Vannes et Auray - P. Chubert
Vannes, , France
CHV André Mignot - Université de Versailles
Versailles, , France
Centre Hospitalier Princesse Grace
Monaco, , Monaco
Countries
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Other Identifiers
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2016-002650-20
Identifier Type: OTHER
Identifier Source: secondary_id
IFM 2017-04
Identifier Type: -
Identifier Source: org_study_id
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