Clinical trial NCT04144387: Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.
Official title: Evaluation of 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 (CARRISMM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoldering Multiple Myeloma
Lead sponsor: Intergroupe Francophone du Myelome
Sponsor class: NETWORK
First posted: 2019-10-30
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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 outcomes:
measure: Assess the annual risk estimated at 2 years of progression from SMM to MM
timeFrame: 2 years
Secondary outcomes:
measure: Assess the risk of progression to MM evaluating biological factors
timeFrame: 5 years
measure: Assess the risk of progression to MM evaluating radiological markers
timeFrame: 5 years
measure: Describe the clonal and sub-clonal evolution of SMM
timeFrame: 5 years
measure: Describe annual risk of progression from SMM to MM at 5 years
timeFrame: 5 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Yvoir
country: Belgium
facility: CHU UCL Namur ASBL Site Godinne
city: Abbeville
country: France
facility: Centre Hospitalier
city: Amiens
country: France
facility: CHU Amiens Sud
city: Angers
country: France
facility: CHRU - Hôpital du Bocage
city: Annecy
country: France
facility: Ch Annecy Genevois
city: Argenteuil
country: France
facility: Centre Hospitalier d'Argenteuil Victor Dupouy
city: Arras
country: France
facility: CH d'Arras
city: Auch
country: France
facility: Centre Hospitalier de Auch
city: Avignon
country: France
facility: Centre Hospitalier H. Duffaut
city: Bayonne
country: France
facility: Centre hospitalier de la Côte Basque
city: Belfort
country: France
facility: Hôpital Nord Franche Comté
city: Blois
country: France
facility: Centre Hospitalier Simone Veil
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Institut Bergonié - Pavillon Saint Genès - 1er étage
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Bourgoin-Jallieu
country: France
facility: Centre hospitalier Pierre Oudot
city: Brest
country: France
facility: CHRU Brest - Hôpital A. Morvan
city: Caen
country: France
facility: CHU Caen - Côte de Nacre
city: Cannes
country: France
facility: Centre Hospitalier
city: Cergy Pontoise
country: France
facility: CH René Dubos
city: Challes-les-Eaux
country: France
facility: Médipôle de Savoie
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier William Morey
city: Chambéry
country: France
facility: CH Chambéry
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dax
country: France
facility: Centre Hospitalier
city: Dijon
country: France
facility: CHU François Mitterand
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Fréjus
country: France
facility: Hôpital de Fréjus
city: Grenoble
country: France
facility: CHU de Grenoble
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: Groupe Hospitalier de La Rochelle
city: Le Havre
country: France
facility: Hospital Jacques Monod
city: Le Mans
country: France
facility: Centre Hospitalier
city: Lens
country: France
facility: Centre Hospitalier
city: Libourne
country: France
facility: Centre hospitalier Robert Boulin
city: Lille
country: France
facility: CHRU Hôpital Claude Huriez
city: Limoges
country: France
facility: Centre Hospitalier Universitaire (CHU) de Limoges
city: Lorient
country: France
facility: Hôpital du Scorff
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Lyon
country: France
facility: Centre Léon Bérard
city: Meaux
country: France
facility: CH Meaux
city: Metz
country: France
facility: Hospital Sainte Blandine
city: Metz
country: France
facility: Hôpital de Mercy (CHR Metz-Thionville)
city: Mont-de-Marsan
country: France
facility: Centre de Recherche Clinique / GHT des Landes
city: Montpellier
country: France
facility: Clinique du Parc
city: Montpellier
country: France
facility: Hopital Saint Eloi - CHU Montpellier
city: Mulhouse
country: France
facility: Hôpital E. Muller
city: Nancy
country: France
facility: CHRU Hôpitaux de Brabois
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nantes
country: France
facility: CHRU Hôtel Dieu
city: Nice
country: France
facility: Hôpital Archet 1
city: Nîmes
country: France
facility: CHU Carémeau, Institut de Cancérologie du Guard
city: Orléans
country: France
facility: CH La Source
city: Paris
country: France
facility: CHU Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: La Pitié
city: Perpignan
country: France
facility: CH Saint Jean
city: Pessac
country: France
facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie
city: Poitiers
country: France
facility: CHU Poitiers - Pôle régional de Cancérologie
city: Périgueux
country: France
facility: Centre Hospitalier de Perigueux
city: Quimper
country: France
facility: Centre Hospitalier de Quimper Cornouaille
city: Reims
country: France
facility: Hôpital Robert Debré
city: Rennes
country: France
facility: CHRU Hôpital de Pontchaillou
city: Rennes
country: France
facility: Hôpital Privé Sévigné
city: Rodez
country: France
facility: Centre Hospitalier Jacques Puel
city: Roubaix
country: France
facility: CH Roubaix
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Brieuc
country: France
facility: Centre Hospitalier Yves Le Foll
city: Saint-Malo
country: France
facility: CH Saint Malo
city: Saint-Priest
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Saint-Quentin
country: France
facility: Centre Hospitalier
city: Strasbourg
country: France
facility: CHU Strasbourg - Hôpital de Hautepierre
city: Strasbourg
country: France
facility: Strasbourg Oncologie Libérale
city: Tarbes
country: France
facility: Centre hospitalier de Tarbes
city: Toulon
country: France
facility: Hôpital Inter-Armées Ste Anne
city: Toulouse
country: France
facility: Pôle IUCT Oncopole CHU
city: Tours
country: France
facility: CHRU Hôpital Bretonneau - Centre Henry Kaplan
city: Troyes
country: France
facility: Centre Hospitalier de Troyes
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Valenciennes
country: France
facility: Centre Hospitalier
city: Vannes
country: France
facility: CH Bretagne Atlantique Vannes et Auray - P. Chubert
city: Versailles
country: France
facility: CHV André Mignot - Université de Versailles
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Rennes University Hospital
name: Pr. Olivier Decaux
role: PRINCIPAL_INVESTIGATOR
References: