MELISSE / Epidemiologie - France Portal

General

Identification

Detailed name

MELISSE

CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation

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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

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)