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An open‐label, single‐arm, phase 2 study of single‐agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have been previously treated with bortezomib
Author(s) -
Vij Ravi,
Siegel David S.,
Jagannath Sundar,
Jakubowiak Andrzej J.,
Stewart Alexander Keith,
McDonagh Kevin,
Bahlis Nizar,
Belch Andrew,
Kunkel Lori A.,
Wear Sandra,
Wong Alvin F.,
Orlowski Robert Z.,
Wang Michael
Publication year - 2012
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2012.09232.x
Subject(s) - carfilzomib , medicine , bortezomib , nausea , refractory (planetary science) , proteasome inhibitor , adverse effect , multiple myeloma , regimen , phases of clinical research , oncology , clinical trial , surgery , physics , astrobiology
Summary Carfilzomib is a next‐generation proteasome inhibitor that selectively and irreversibly binds to its target. In clinical studies, carfilzomib has shown efficacy in patients with relapsed and/or refractory multiple myeloma ( MM ) and has demonstrated a tolerable safety profile. In this phase 2, open‐label, multicentre clinical trial, 35 patients with relapsed and/or refractory MM following 1–3 prior therapies, including at least one bortezomib‐based regimen, received carfilzomib 20 mg/m 2 in a twice‐weekly, consecutive‐day dosing schedule for ≤12 monthly cycles. The best overall response rate ( ORR ) was 17·1% and the clinical benefit response rate ( ORR + minimal response) was 31·4%. The median duration of response was >10·6 months and the median time to progression was 4·6 months. The most common adverse events were fatigue (62·9%), nausea (60·0%), and vomiting (42·9%). No exacerbation of baseline peripheral neuropathy was observed. Single‐agent carfilzomib was generally well tolerated for up to 12 treatment cycles and showed activity in patients with relapsed and/or refractory MM who had received prior treatment with bortezomib. These data, combined with an acceptable toxicity profile, support the potential use of carfilzomib in patients with relapsed and/or refractory MM and warrant continued investigation of carfilzomib as single agent or in combination with other agents.