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

NCT04811508 | Completed

• 1 other identifier: CHM-2020/S14/07
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsed Multiple Myeloma

Keywords

relapsed multiple myeloma; Carfilzomib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to next treatment

  31 august 2021

• Progression Free survival (PFS)

  31 august 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: August 4, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 9, 2022

Record last verified: 2021-03

Locations

FR (1)