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Clinical Trials in France / NCT04144387
Active, not recruiting Not applicable

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

NCT04144387 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-02-11
Last updated
2024-03-06

Condition(s) studied

Smoldering Multiple Myeloma

Investigational drug(s) / intervention(s)

Myelogram

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)

Trial sites (90)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT04144387 on ClinicalTrials.gov ↗ ← All trials in France