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NCT03679351 Clinical Trial

"FU-IFM2009" Database Post IFM/DFCI 2009 Study

Multiple Myeloma Clinical Trial

— DB-FU-IFM2009  

Official title:
"Follow Up-Intergroupe Francophone du Myélome 2009" Database Post IFM/DFCI 2009 Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03679351
Other study ID # RC31/18/221
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2018
Est. completion date November 30, 2020

Study information
Verified date July 2020
Source University Hospital, Toulouse
Contact Michel ATTAL, MD PhD
Phone 05 31 15 50 01
Email michel.attal@iuct-oncopole.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Extension of patient follow-up of the IFM/DFCI 2009 study over a period of 4 years (that is, from 01 December 2016 to 30 November 2020) during which patients will be followed up in the normal course of care and according to the usual care of the centers, with collection of the needed data about twice a year by the investigators

Recruitment information / eligibility
Status Recruiting
Enrollment 675
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patient randomized in the IFM/DFCI 2009 study.

- Patient still alive must give their non-opposition to the post IFM/DFCI 2009 study data collection until 30 November 2020

- Patient non-opposition.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU de Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression free survival number of deaths 4 years
Secondary overall long-term survival number of deaths 4 years
Secondary secondary primary malignancies number of secondary primary malignancies 4 years
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