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

Study Overview
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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).

Official Title
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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

Conditions
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Relapsed Multiple Myeloma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of carfilzomib treatment | Assess duration of carfilzomib treatment in adult patients with multiple myeloma who have received carfilzomib at first or second relapse according to the recommendations of the International Myeloma Working Group (time from the date of treatment initiation to the date of permanent discontinuation for any reason) | 31 august 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to next treatment | This is defined as the time from the date of treatment initiation (i.e. the date of the first day of the first cycle of the treatment with carfilzomib) to the date when the next line starts. Time to next treatment is censored at the date of death, if applicable. Patients still on carfilzomib treatment at the end of the study will be censored at the date of the last disease evaluation | 31 august 2021 | 
| Progression Free survival (PFS) | Progression free survival is defined as the time from the date of initiation of treatment (i.e. the date of the first day of the first cycle of treatment with carfilzomib) to the date of the first disease progression, as defined by the investigator's judgement using IMWG criteria (1), or the date of death, whichever occurs first. Progression free survival is censored at the date of the last disease evaluation, if applicable | 31 august 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed multiple myeloma, Carfilzomib