"FU-IFM2009" Database Post IFM/DFCI 2009 Study | NCT03679351

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

NCT03679351

Sponsor

University Hospital, Toulouse

Status

Unknown status

Last Update Posted

Jul 30, 2020Actual

Enrollment

675Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2018Actual

Primary Completion Date

Nov 30, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Sep 19, 2018

First Submission Date that Met QC Criteria

Sep 19, 2018

First Posted Date

Sep 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2020

Last Update Posted Date

Jul 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

675Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival	number of deaths	4 years

Secondary Outcomes

Measure	Description	Time Frame
overall long-term survival	number of deaths	4 years
secondary primary malignancies	number of secondary primary malignancies	4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have been already randomized in the IFM/DFCI 2009 study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michel ATTAL, MD PhD	Contact	05 31 15 50 01	+33	michel.attal@iuct-oncopole.fr
Laura BOGDANOVITCH	Contact	05 61 77 84 37	+33	bogdanovitch.l@chu-toulouse.fr

Overall Officials

Name	Affiliation	Role
Michel Attal, MD PhD	University Hosptial toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Toulouse	Recruiting	Toulouse		31059	France

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided