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"FU-IFM2009" Database Post IFM/DFCI 2009 Study (DB-FU-IFM2009)

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ClinicalTrials.gov Identifier: NCT03679351
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief 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

Condition or disease
Multiple Myeloma

Study Design
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Study Type : Observational
Estimated Enrollment : 675 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: "Follow Up-Intergroupe Francophone du Myélome 2009" Database Post IFM/DFCI 2009 Study
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. progression free survival [ Time Frame: 4 years ]
    number of deaths


Secondary Outcome Measures :
  1. overall long-term survival [ Time Frame: 4 years ]
    number of deaths

  2. secondary primary malignancies [ Time Frame: 4 years ]
    number of secondary primary malignancies


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been already randomized in the IFM/DFCI 2009 study
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679351


Contacts
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Contact: Michel ATTAL, MD PhD 05 31 15 50 01 ext +33 michel.attal@iuct-oncopole.fr
Contact: Laura BOGDANOVITCH 05 61 77 84 37 ext +33 bogdanovitch.l@chu-toulouse.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Michel ATTAL, PhD    05 31 15 50 01 ext +33    michel.attal@iuct-oncopole.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Michel Attal, MD PhD University Hosptial toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03679351    
Other Study ID Numbers: RC31/18/221
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases