NCT03679351

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
675

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

September 19, 2018

Last Update Submit

July 29, 2020

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    number of deaths

    4 years

Secondary Outcomes (2)

  • overall long-term survival

    4 years

  • secondary primary malignancies

    4 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Michel Attal, MD PhD

    University Hosptial toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel ATTAL, MD PhD

CONTACT

05 31 15 50 01michel.attal@iuct-oncopole.fr

Laura BOGDANOVITCH

CONTACT

05 61 77 84 37bogdanovitch.l@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 20, 2018

Study Start

July 15, 2018

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

FR(1)