title: Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study.
abstract: 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.
  
  
  
  clinicaltrials.gov identifier: NCT01080391.
authors.affiliation: National and Kapodistrian University of Athens, Athens, Greece.
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.affiliation: Mayo Clinic, Scottsdale, AZ, USA.
authors.forename: A Keith
authors.initials: AK
authors.lastname: Stewart
authors.affiliation: St István and St Laszlo Hospital, 3rd Dept. of Internal Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: Tamás
authors.initials: T
authors.lastname: Masszi
authors.affiliation: First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
authors.forename: Ivan
authors.initials: I
authors.lastname: Špička
authors.affiliation: Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Barcelona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.affiliation: University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
authors.forename: Roman
authors.initials: R
authors.lastname: Hájek
authors.affiliation: Hospital Clínic de Barcelona, Barcelona, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Rosiñol
authors.affiliation: John Theurer Cancer Center at Hackensack University, Hackensack, NJ, USA.
authors.forename: David
authors.initials: D
authors.lastname: Siegel
authors.affiliation: Queen Joanna University Hospital, Sofia, Bulgaria.
authors.forename: Georgi G
authors.initials: GG
authors.lastname: Mihaylov
authors.affiliation: Haematology Clinic University Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria.
authors.forename: Vesselina
authors.initials: V
authors.lastname: Goranova-Marinova
authors.affiliation: Department of Haematology, Mór Kaposi Teaching Hospital, Kaposvár, Hungary.
authors.forename: Péter
authors.identifier: 0000-0003-3985-5826
authors.initials: P
authors.lastname: Rajnics
authors.affiliation: Haematological Department, First Republican Clinical Hospital of Udmurtia, Izhevsk, Russia.
authors.forename: Aleksandr
authors.initials: A
authors.lastname: Suvorov
authors.affiliation: Weill Cornell Medical College, New York, NY, USA.
authors.forename: Ruben
authors.initials: R
authors.lastname: Niesvizky
authors.affiliation: University of Chicago Medical Center, Chicago, IL, USA.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Jakubowiak
authors.affiliation: Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain.
authors.forename: Jesus
authors.initials: J
authors.lastname: San-Miguel
authors.affiliation: Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.affiliation: University of Torino, Torino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.affiliation: Onyx Pharmaceuticals, Inc. an Amgen subsidiary, South San Francisco, CA, USA.
authors.forename: Mihaela
authors.initials: M
authors.lastname: Obreja
authors.affiliation: Onyx Pharmaceuticals, Inc. an Amgen subsidiary, South San Francisco, CA, USA.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Aggarwal
authors.affiliation: University of Nantes, Nantes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D009842:Oligopeptides / Q000008:administration & dosage; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D009842:Oligopeptides; D013792:Thalidomide; C524865:carfilzomib; D003907:Dexamethasone; D000077269:Lenalidomide
keywords: carfilzomib; clinical trial; dexamethasone; lenalidomide; relapsed multiple myeloma