ClinTrial Refer

Trial Acronym
CARRISMM IFM 2017-04

Registration Number
NCT04144387

Scientific 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)

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.

-  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.

-  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)

Trial Location Name

Address

Status

Groupe hospitalier Bretagne Sud - Lorient

5 Avenue Choiseul, 56100 Lorient, France

Closed

Primary Contact : Adrien Trebouet (IFM), a.trebouet@ghbs.bzh , 02.97.64.91.85, poste 69674

Hôpital d'instruction des armées Sainte-Anne

2 Boulevard Sainte-Anne, 83000 Toulon, France

Closed

Primary Contact : Jean-Pierre De Jaureguiberry (IFM), oncologie@sainteanne.org , 04 83 16 20 10 et 20 14

Hôpital de Fréjus - Saint-Raphaël

240 Avenue de Saint-Lambert, 83600 Fréjus, France

Closed

Primary Contact : Jean Gutnecht (IFM), gutnecht-j@chi-fsr.fr , 04 94 40 20 56

Hôpital Jacques Monod (Groupe Hospitalier du Havre)

29 Avenue Pierre Mendès France, 76290 Montivilliers, France

Closed

Primary Contact : Charles Zarnitsky (IFM), charles.zarnitsky@ch-havre.fr , 02 32 73 33 78

Hôpital privé du Confluent SAS Centre Catherine de Sienne

2-4 Rue Éric Tabarly, 44200 Nantes, France

Closed

Primary Contact : Jacques Delaunay (IFM), jacques.delaunay@groupeconfluent.fr , 02 28 27 21 16

Hôpital Privé Sévigné

3 Rue du Chêne Germain, 35510 Cesson-Sévigné, France

Closed

Primary Contact : Benoit Bareau (IFM), benoit.bareau@gmail.com , 02 23 21 05 50

Hôpital Sainte-Blandine - HPMetz

3 Rue du Cambout, 57000 Metz, France

Closed

Primary Contact : Elena Loppinet (IFM), elena.loppinet@hp-metz.fr , 03 57 84 15 87

Institut Bergonié

299 Cours de l'Argonne, Bordeaux, France

Closed

Primary Contact : Pierre Soubeyran (LYSA), p.soubeyran@bordeaux.unicancer.fr , +33 5 56 33 33 33

Secondary Contact : Anna Schmitt (IFM), a.schmitt@bordeaux.unicancer.fr , +33 556330412

Institut Curie

26 Rue d'Ulm, 75005 Paris, France

Closed

Primary Contact : Frédérique Kuhnowski (IFM) , frederique.kuhnowski@curie.fr , 33 (0)1 56 24 55 00

Institut Daniel Hollard Grenoble - Groupe Hospitalier Mutualiste de Grenoble

21 Rue du Dr Hermite, Grenoble, France

Closed

Primary Contact : Leyronnas-Assouline (LYSA), contact@lysa-lymphoma.org , +33 4 76 70 73 61

Secondary Contact : Nicolas Albin (IFM) , n.albin@ghm-grenoble.fr , +33 476285232

Institut de CancérologieLucien Neuwirth St Etienne

Saint-Priest-en-Jarez, France

Closed

Primary Contact : Jerome Cornillon (LYSA), jerome.cornillon@icloire.fr , +33 4 77 91 70 00

Secondary Contact : Denis Guyotat (IFM) , denis.guyotat@icloire.fr , +33 477917000

Polyclinique Bordeaux Nord Aquitaine

15-35 Rue Claude Boucher, Bordeaux, France

Closed

Primary Contact : Olivier Fitoussi (LYSA) (IFM), o.fitoussi@bordeauxnord.com , +33 5 56 43 71 11

Intergroupe Francophone du Myelome

Website URL

Link Name

Link URL

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT04144387

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Not Applicable

Minimum Age
18

Maximum Age
120

Date Registered
11/02/2020

Date Closed
N/A

Status
Closed

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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