- MELISSE

Head :
Lamblin Anne, LEO Pharma France

Last update : 07/22/2015 | Version : 2 | ID : 96

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name MELISSE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation --
General Aspects
Medical area Cancer research
Keywords prophylaxis, thalidomide, lenalidomide
Scientific investigator(s) (Contact)
Name of the director Lamblin
Surname Anne
Address LEO Pharma France - 6 rue Jean-Pierre Timbaud - 78180 MONTIGNY LE BRETONNEUX
Phone + 33 (0)1 30 14 40 00
Email anne.lamblin@leo-pharma.com
Unit LEO Pharma France
Organization LEO Pharma
Collaborations
Funding
Funding status Public
Details LEO Pharma
Governance of the database
Sponsor(s) or organisation(s) responsible Laboratoire LEO pharma
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. There is no random sampling - all subjects meeting the criteria are included
Database objective
Main objective Describe the prophylactic treatment of phlebitis in patients suffering from multiple myeloma and receiving thalidomide or lenalidomide treatment:
- Describe the proportion of patients under prophylactic treatment for phlebitis;
- Define the importance of low-molecular-weight heparins (LMWH), vitamin K antagonists (VKA) and aspirin, as well as the arrangements for their use in preventing phlebitis.

Describe, over a period of 4 and then 8 months, the occurrence of thromboembolic and hemorrhagic events in patients with multiple myeloma who are under thalidomide or lenalidomide treatment, depending on the thromboprophylactic strategy set up upon inclusion
Inclusion criteria Adult patient with introduction to thalidomide or lenalidomide treatment for multiple myeloma (1st, 2nd or 3rd line of chemotherapy).
Non-inclusion criteria: patient participating or having participated over the previous three months in a biomedical trial on anticoagulants
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered General population
Gender Male
Woman
Geography area National
Detail of the geography area 60 hospitals with a hemato-oncology unit, based in mainland France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2008
Date of last collection (YYYY or MM/YYYY) 2011
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 600
Data
Database activity Current data collection
Type of data collected Clinical data
Clinical data (detail) Direct physical measures
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Care consumption (detail) Medicines consumption
Procedures
Data collection method - Center questionnaire: to be completed by centers agreeing to take part in the trial.- Data collection booklet: to be completed by the participant physicians for each patient screened and each patient included
Participant monitoring Yes
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=Lamblin+A[author]+AND+Melisse
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) 3 oral presentations will be given about the trial at international congresses (ASH,ISTH,EHA)
Article submitted for publication
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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