ITMO public health
Last update : 09/05/2017 | Version : 3 | ID : 3195
| General | |
| Identification | |
| Detailed name | Velcade: study of real-life use |
| Sign or acronym | VESUVE (beta) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 05 375, CNIL 1133894 |
| General Aspects | |
| Medical area |
Cancer research Hematology |
| Keywords | Multiple myeloma, Velcade®, Bortezomib, survival, conditions of use, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Fourrier-Reglat |
| Surname | Annie |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33(0)5 57 57 46 75 |
| Annie.fourrier@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@u-bordeaux.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Laboratoire Janssen-Cilag France (soutien inconditionnel) - Janssen-Cilag France (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| 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 care professionals 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. | All hospital pharmacies that purchased bortezomib at the time of study implementation were contacted. Pharmacists of participating centres have, from nominative dispensation registers, identified patients who received a first prescription of bortezomib during the study period. The prescribing physicians were contacted and asked to participate in the study. Participating physcians informed patients of the study and gave access to medical records to the CRAs in charge of the data collection. |
| Database objective | |
| Main objective | The objectives are to evaluate the response and survival of patients treated by Velcade®, to describe the population of patients initiating treatment with Velcade® (socio-demographic data, previous treatments, indication), and describe the conditions of use Velcade® (dose, number and frequency of treatment cycles) |
| Inclusion criteria | Patients initiating Bortezomib treatment between 1 May 2004 and April 30 2006 (whether or not treatment is continued); Patient unexposed to bortezomib, including during a clinical trial or temporary use authorization; Patient followed by a hospital physician having agreed to participate in the study; Patient not participating in a clinical trial; Patient not objecting to data collection |
| 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 |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Hospital pharmacists and physicians in metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2004 |
| Date of last collection (YYYY or MM/YYYY) | 2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 1310 patients identified by hospital pharmacists, including 924 patients for whom their physician agreed to participate in the study, and 793 patients were eligible for follow up. |
| Data | |
| Database activity |
Data collection completed |
| 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 | CRAs have collected data on site using a standardized electronic case report forms (e-CRF). The indication for treatment with bortezomib was collected for all patients, but only those treated for multiple myeloma were followed. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Patients treated for multiple myeloma are followed over three years (from the date of first administration of Velcade®) using data available in medical records. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23808815 |
| Link to the document | http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | A confidential study report was submitted to the pharmaceutical company and sent to health authorities after validation by the study Scientific Committee. Ownership of study data was the subject of an agreement between the University of Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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