- MELISSE
Head :
Lamblin Anne, LEO Pharma France
Last update : 07/22/2015 | Version : 2 | ID : 96
| 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 |
| 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 |
