UNLABELLED: A primary analysis of the ASPIRE study found that the addition of carfilzomib to lenalidomide and dexamethasone (carfilzomib group) significantly improved progression-free survival (PFS) compared with lenalidomide and dexamethasone alone (control group) in patients with relapsed multiple myeloma (RMM). This post hoc analysis examined outcomes from ASPIRE in patients categorised by age. In the carfilzomib group, 103/396 patients were ≥70 years old, and in the control group, 115/396 patients were ≥70 years old. Median PFS for patients <70 years old was 28·6 months for the carfilzomib group versus 17·6 months for the control group [hazard ratio (HR), 0·701]. Median PFS for patients ≥70 years old was 23·8 months for the carfilzomib group versus 16·0 months for the control group (HR, 0·753). For patients <70 years the overall response rate (ORR) was 86·0% (carfilzomib group) and 66·9% (control group); for patients ≥70 years old the ORR was 90·3% (carfilzomib group) and 66·1% (control group). Within the carfilzomib group, grade ≥3 cardiovascular adverse events occurred more frequently among patients ≥70 years old compared with patients <70 years old. Carfilzomib-lenalidomide-dexamethasone has a favourable benefit-risk profile for patients with RMM, including elderly patients ≥70 years old. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01080391.

1st Faculty of Medicine Charles University Prague Prague Czech Republic

Clinica Universidad de Navarra CIMA IDISNA Pamplona Spain

Department of Haematology Mór Kaposi Teaching Hospital Kaposvár Hungary

Haematological Department 1st Republican Clinical Hospital of Udmurtia Izhevsk Russia

Haematology Clinic University Multiprofile Hospital for Active Treatment Plovdiv Bulgaria

Hospital Clínic de Barcelona Barcelona Spain

Institut Català d'Oncologia Hospital Germans Trias i Pujol Barcelona Spain

John Theurer Cancer Center at Hackensack University Hackensack NJ USA

Mayo Clinic Scottsdale AZ USA

National and Kapodistrian University of Athens Athens Greece

Onyx Pharmaceuticals Inc an Amgen subsidiary South San Francisco CA USA

Queen Joanna University Hospital Sofia Bulgaria

St István and St Laszlo Hospital 3rd Dept of Internal Medicine Semmelweis University Budapest Hungary

University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

University of Chicago Medical Center Chicago IL USA

University of Nantes Nantes France

University of Torino Torino Italy

Weill Cornell Medical College New York NY USA

Wilhelminen Cancer Research Institute Wilhelminenspital Vienna Austria

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Once- versus twice-weekly carfilzomib in relapsed and refractory multiple myeloma by select patient characteristics: phase 3 A.R.R.O.W. study subgroup analysis

Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies

Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials

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ClinicalTrials.gov
NCT01080391