Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.

NCT04144387 | Active Not Recruiting

• 2 other identifiers: IFM 2017-042016-002650-20
• Study Type: interventional
• Target: 395
• Locations: 3 countries
• Sites: 90

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.

Conditions

Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Secondary Outcomes (4)

• Assess the risk of progression to MM evaluating biological factors

  5 years

• Assess the risk of progression to MM evaluating radiological markers

  5 years

• Describe the clonal and sub-clonal evolution of SMM

  5 years

• Describe annual risk of progression from SMM to MM at 5 years

  5 years

Study Arms (1)

Test group

EXPERIMENTAL

Each patient included in the study will be followed for 5 years

Procedure: Myelogram

Interventions

Myelogram PROCEDURE

Two additional myelograms will be performed comparing to standard of care.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able and willing to give valid written informed consent. Patients must give written informed consent (IC) in accordance with institutional and local guidelines.

You may not qualify if:

• 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)
• Amyloidosis
• POEMS syndrome
• Contraindication to MRI
• Pregnancy

Sponsors & Collaborators

• Intergroupe Francophone du Myelome: lead

Study Sites (90)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

CHU UCL Namur ASBL Site Godinne

Yvoir, Belgium

Location

Centre Hospitalier

Abbeville, France

Location

CHU Amiens Sud

Amiens, France

Location

CHRU - Hôpital du Bocage

Angers, France

Location

Ch Annecy Genevois

Annecy, France

Location

Centre Hospitalier d'Argenteuil Victor Dupouy

Argenteuil, France

Location

CH d'Arras

Arras, France

Location

Centre Hospitalier de Auch

Auch, France

Location

Centre Hospitalier H. Duffaut

Avignon, France

Location

Centre hospitalier de la Côte Basque

Bayonne, France

Location

Hôpital Nord Franche Comté

Belfort, France

Location

Centre Hospitalier Simone Veil

Blois, France

Location

Hôpital Avicenne

Bobigny, France

Location

Institut Bergonié - Pavillon Saint Genès - 1er étage

Bordeaux, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Location

Centre hospitalier Pierre Oudot

Bourgoin, France

Location

CHRU Brest - Hôpital A. Morvan

Brest, France

Location

CHU Caen - Côte de Nacre

Caen, France

Location

Centre Hospitalier

Cannes, France

Location

CH René Dubos

Cergy-Pontoise, France

Location

Médipôle de Savoie

Challes-les-Eaux, France

Location

Centre Hospitalier William Morey

Chalon-sur-Saône, France

Location

CH Chambéry

Chambéry, France

Location

Hôpital d'Instruction des Armées Percy

Clamart, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

CHU Henri Mondor

Créteil, France

Location

Centre Hospitalier

Dax, France

Location

CHU François Mitterand

Dijon, France

Location

Centre Hospitalier de Dunkerque

Dunkirk, France

Location

Hôpital de Fréjus

Fréjus, France

Location

CHU de Grenoble

Grenoble, France

Location

Institut Daniel Hollard

Grenoble, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Groupe Hospitalier de La Rochelle

La Rochelle, France

Location

Hospital Jacques Monod

Le Havre, France

Location

Centre Hospitalier

Le Mans, France

Location

Centre Hospitalier

Lens, France

Location

Centre hospitalier Robert Boulin

Libourne, France

Location

CHRU Hôpital Claude Huriez

Lille, France

Location

Centre Hospitalier Universitaire (CHU) de Limoges

Limoges, France

Location

Hôpital du Scorff

Lorient, France

Location

Centre Hospitalier Lyon Sud

Lyon, France

Location

Centre Léon Bérard

Lyon, France

Location

CH Meaux

Meaux, France

Location

Hospital Sainte Blandine

Metz, France

Location

Hôpital de Mercy (CHR Metz-Thionville)

Metz, France

Location

Centre de Recherche Clinique / GHT des Landes

Mont-de-Marsan, France

Location

Clinique du Parc

Montpellier, France

Location

Hopital Saint Eloi - CHU Montpellier

Montpellier, France

Location

Hôpital E. Muller

Mulhouse, France

Location

CHRU Hôpitaux de Brabois

Nancy, France

Location

Centre Catherine de Sienne

Nantes, France

Location

CHRU Hôtel Dieu

Nantes, France

Location

Hôpital Archet 1

Nice, France

Location

CHU Carémeau, Institut de Cancérologie du Guard

Nîmes, France

Location

CH La Source

Orléans, France

Location

CHU Hôpital Saint Antoine

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Necker

Paris, France

Location

Hôpital Saint Louis

Paris, France

Location

La Pitié

Paris, France

Location

CH Saint Jean

Perpignan, France

Location

CHRU - Hôpital du Haut Lévêque - Centre François Magendie

Pessac, France

Location

Centre Hospitalier de Perigueux

Périgueux, France

Location

CHU Poitiers - Pôle régional de Cancérologie

Poitiers, France

Location

Centre Hospitalier de Quimper Cornouaille

Quimper, France

Location

Hôpital Robert Debré

Reims, France

Location

CHRU Hôpital de Pontchaillou

Rennes, France

Location

Hôpital Privé Sévigné

Rennes, France

Location

Centre Hospitalier Jacques Puel

Rodez, France

Location

CH Roubaix

Roubaix, France

Location

Centre Henri Becquerel

Rouen, France

Location

Centre Hospitalier Yves Le Foll

Saint-Brieuc, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest, France

Location

Centre Hospitalier

Saint-Quentin, France

Location

CH Saint Malo

St-Malo, France

Location

CHU Strasbourg - Hôpital de Hautepierre

Strasbourg, France

Location

Strasbourg Oncologie Libérale

Strasbourg, France

Location

Centre hospitalier de Tarbes

Tarbes, France

Location

Hôpital Inter-Armées Ste Anne

Toulon, France

Location

Pôle IUCT Oncopole CHU

Toulouse, France

Location

CHRU Hôpital Bretonneau - Centre Henry Kaplan

Tours, France

Location

Centre Hospitalier de Troyes

Troyes, France

Location

Centre Hospitalier de Valence

Valence, France

Location

Centre Hospitalier

Valenciennes, France

Location

CH Bretagne Atlantique Vannes et Auray - P. Chubert

Vannes, France

Location

CHV André Mignot - Université de Versailles

Versailles, France

Location

Centre Hospitalier Princesse Grace

Monaco, Monaco

Location

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Interventions

Myelography

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Pr. Olivier Decaux

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 30, 2019
• Study Start: February 11, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (86); MO (1)