NCT06154902

Brief Summary

The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress70%
Jul 2022Dec 2027

Study Start

First participant enrolled

July 29, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

November 27, 2023

Last Update Submit

November 27, 2023

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    15 years

Study Arms (2)

Treated with idecabtagene vicleucel

Drug: Idecabtagene vicleucel

Eligible for idecabtagene vicleucel

Eligible for idecabtagene vicleucel treatment but not treated

Other: Not treated

Interventions

Idecabtagene vicleucelDRUG

According to approved product label in France

Treated with idecabtagene vicleucel
Not treatedOTHER

Eligible for idecabtagene vicleucel treatment but not treated

Eligible for idecabtagene vicleucel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in France with RRMM who are eligible for treatment with, or have been treated with, idecabtagene vicleucel

You may qualify if:

  • Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel

You may not qualify if:

  • Not registered with the social security in France

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DESCAR-T Registry

Paris, France

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

idecabtagene vicleucel

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

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
15 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 4, 2023

Study Start

July 29, 2022

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)