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Completed

NCT Number: NCT04811508

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

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Duration of carfilzomib treatment

    Time frame: 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 outcomes

  1. Time to next treatment

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: CARMYN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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