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Clinical trial

A Non-interventional Study of Carfilzomib (Kyprolis®) in Combination With Lenalidomide (Revlimid®) and Dexamethasone or Carfilzomib in Combination With Dexamethasone Alone or Carfilzomib in Combination With Daratumumab (Darzalex®) and Dexamethasone in Patients With Multiple Myeloma Who Have Received at Least One Prior Therapy

ID
Name
IOM-070337
Description
The objective of this non-interventional study (NIS) is to evaluate patients' adherence and persistence to carfilzomib therapy in combination with lenalidomide and dexamethasone or in combination with dexamethasone alone or in combination with daratumumab and dexamethasone in adult patients with multiple myeloma (MM) who have received at least one prior therapy in a real-life setting.
Trial arms
Trial start
2016-10-25
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Active (not recruiting)
Treatment
Carfilzomib
In accordance with SmPC.
Arms:
Car/Dex (Kd), Car/Dex/Dara (KdD), Car/Len/Dex (KRd)
Other names:
Kyprolis®
Size
359
Primary endpoint
Patients' adherence and persistence to carfilzomib therapy
Duration of Carfilzomib therapy, up to 24 months after last patient in
Eligibility criteria
Inclusion Criteria: * Aged 18 years or older. * Patients with MM who have received at least one prior therapy. * Indication for treatment as assessed by the treating physician. * Decision for second- or subsequent-line treatment with the combination therapy carfilzomib/ lenalidomide/ dexamethasone or carfilzomib/ dexamethasone or carfilzomib/ dexamethasone/ daratumumab * Signed written informed consent. * Criteria according to the current Summary of Product Characteristics (SmPC) for Kyprolis® (Carfilzomib) Exclusion Criteria: * Contraindications according to the current SmPC for Kyprolis® (Carfilzomib)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 359, 'type': 'ACTUAL'}}
Updated at
2023-07-10

1 organization

1 product

1 indication

Organization
iOMEDICO
Product
Carfilzomib
Indication
Multiple Myeloma in Relapse