Publications by authors named "Ievgenii Karamanesht"
Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study.
Lancet Oncol
January 2016
Article Synopsis
- The study aims to compare the effectiveness of carfilzomib combined with dexamethasone versus the standard bortezomib with dexamethasone in treating patients with relapsed or refractory multiple myeloma.
- It involved a randomized, phase 3 trial with 929 patients who had undergone one to three prior treatments, and measured the primary endpoint of progression-free survival.
- The findings indicate a median follow-up period of approximately 11.9 months for the carfilzomib group and 11.1 months for the bortezomib group.
Background And Objectives: The proteasome inhibitor bortezomib is approved for the treatment of multiple myeloma (MM) and, in the US, for the treatment of mantle cell lymphoma following at least one prior therapy; the recommended dose and schedule is 1.3 mg/m(2) on days 1, 4, 8 and 11 of 21-day cycles, and the approved routes of administration in the US prescribing information are by intravenous and, following a recent update, subcutaneous injection. Findings from a phase III study demonstrated that subcutaneous administration of bortezomib, using the same dose and schedule, resulted in similar efficacy with an improved systemic safety profile (including significantly lower rates of peripheral neuropathy) versus intravenous bortezomib in patients with relapsed MM.
View Article and Find Full Text PDFThe phase III MMY-3021 study compared safety and efficacy of subcutaneous versus intravenous administration of the proteasome inhibitor bortezomib in patients with relapsed myeloma. The initial report demonstrated non-inferior efficacy with subcutaneous versus intravenous bortezomib for the primary end point: overall response rate after four cycles of single-agent bortezomib. We report updated outcome analyses after prolonged follow up.
View Article and Find Full Text PDFBackground: Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We compared the efficacy and safety of subcutaneous versus intravenous bortezomib at the approved 1·3 mg/m(2) dose and twice per week schedule in patients with relapsed multiple myeloma.
Methods: This randomised, phase 3 study was undertaken at 53 centres in ten countries in Europe, Asia, and South America.