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 (CARMYN)

• ClinicalTrials.gov Identifier: NCT04811508
• Recruitment Status: Completed
• First Posted: March 23, 2021
• Last Update Posted: March 9, 2022
• Sponsor: Centre Hospitalier le Mans
• Information provided by (Responsible Party): Centre Hospitalier le Mans

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
Relapsed Multiple Myeloma

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: August 4, 2020
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France

Criteria

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

France

Centre Hospitalier Du Mans

Le Mans, France, 72000

Sponsors and Collaborators

Centre Hospitalier le Mans

More Information

• Responsible Party: Centre Hospitalier le Mans
• ClinicalTrials.gov Identifier: NCT04811508
• Other Study ID Numbers: CHM-2020/S14/07
• First Posted: March 23, 2021
• Last Update Posted: March 9, 2022
• Last Verified: March 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; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases