Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use

NCT ID: NCT04811508

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2021-12-31

Brief Summary

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This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).

Detailed Description

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Conditions

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Relapsed Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients over the age of 18 years
* Patients beginning carfilzomib treatment in the framework of expanded access or compassionate use in France (KRd or Kd regimen)
* Patients who received carfilzomib in first or second MM relapse
* Patients receiving at least one complete course of carfilzomib

Exclusion Criteria

* Patients already included in an interventional research protocol using carfilzomib at the time of treatment initiation
* Patients refusing to allow the computerization of their data
* Patients for whom hospital medical records are not accessible
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Du Mans

Le Mans, , France

Site Status

Countries

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France

Other Identifiers

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CHM-2020/S14/07

Identifier Type: -

Identifier Source: org_study_id

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