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CARMYN: 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

Sponsor
Centre Hospitalier le Mans (Other)
Overall Status
Completed
CT.gov ID
NCT04811508
Collaborator
(none)
172
Enrollment
1
Location
16.9
Actual Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    172 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    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
    Actual Study Start Date :
    Aug 4, 2020
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Duration of carfilzomib treatment [31 august 2021]

      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)

    Secondary Outcome Measures

    1. Time to next treatment [31 august 2021]

      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

    2. Progression Free survival (PFS) [31 august 2021]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Du Mans Le Mans France 72000

    Sponsors and Collaborators

    • Centre Hospitalier le Mans

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier le Mans
    ClinicalTrials.gov Identifier:
    NCT04811508
    Other Study ID Numbers:
    • CHM-2020/S14/07
    First Posted:
    Mar 23, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier le Mans
    relapsed multiple myeloma
    Carfilzomib
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Mar 9, 2022