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
| Autor: | Kevin T. McDonagh, Andrzej Jakubowiak, Sandra Wear, Michael Wang, Nizar J. Bahlis, Robert Z. Orlowski, Alexander Keith Stewart, David S. Siegel, Andrew Belch, Alvin F. Wong, Lori Kunkel, Sundar Jagannath, Ravi Vij |
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| Rok vydání: | 2012 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Phases of clinical research Antineoplastic Agents Article Bortezomib chemistry.chemical_compound Refractory Recurrence Internal medicine medicine Humans Protease Inhibitors Adverse effect Multiple myeloma Fatigue Aged Gastrointestinal Neoplasms business.industry Hematology Middle Aged medicine.disease Carfilzomib Boronic Acids Hematologic Diseases Surgery Regimen Treatment Outcome chemistry Drug Resistance Neoplasm Pyrazines Proteasome inhibitor Disease Progression Female business Multiple Myeloma Oligopeptides medicine.drug |
| Zdroj: | British journal of haematology. 158(6) |
| ISSN: | 1365-2141 |
| Popis: | 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 171% and the clinical benefit response rate (ORR + minimal response) was 314%. The median duration of response was >106 months and the median time to progression was 46 months. The most common adverse events were fatigue (629%), nausea (600%), and vomiting (429%). 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. |
| Databáze: | OpenAIRE |
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