Details

Autor(en) / Beteiligte

• Iida, Shinsuke
• Watanabe, Takashi
• Matsumoto, Morio
• Suzuki, Kenshi
• Sunami, Kazutaka
• Ishida, Tadao
• Ando, Kiyoshi
• Chou, Takaaki
• Ozaki, Shuji
• Taniwaki, Masafumi
• Uike, Naokuni
• Shibayama, Hirohiko
• Hatake, Kiyohiko
• Izutsu, Koji
• Ishikawa, Takayuki
• Shumiya, Yoshihisa
• Tobinai, Kensei

Titel

Carfilzomib monotherapy in Japanese patients with relapsed or refractory multiple myeloma: A phase 1/2 study

Ist Teil von

• Cancer science, 2019-09, Vol.110 (9), p.2924-2932

Ort / Verlag

England: John Wiley & Sons, Inc

Erscheinungsjahr

2019

Link zum Volltext

Quelle

Wiley-Blackwell subscription journals

Beschreibungen/Notizen

• This multicenter, open‐label phase 1/2 study evaluated single‐agent carfilzomib in 50 heavily pretreated Japanese patients with relapsed/refractory multiple myeloma (median of five prior treatments). In phase 1, patients were dosed at three levels: 15, 20, or 20/27 mg/m2. Maximum tolerated dosage was not reached at the tolerability evaluation. Patients in phase 2 were treated with 20/27 mg/m2 carfilzomib. Median duration of exposure to carfilzomib in the 20/27 mg/m2 group at this final analysis was 4.7 months (range: 0.3‐39.4). Overall response rate in the 20/27 mg/m2 group, primary endpoint of the study, was 22.5% (n = 9) (95% confidence interval, 12.3‐37.5) with 2.5% (n = 1) stringent complete response. Median progression‐free survival and overall survival in the 20/27 mg/m2 group were 5.1 months (95% CI, 2.8‐13.6) and 22.9 months (95% CI, 14.1‐not estimable), respectively. Frequently occurring grade ≥3 adverse events in the 20/27 mg/m2 group included lymphopenia (72.5%), neutropenia (40.0%), and leukopenia (32.5%). Giving long‐term carfilzomib monotherapy led to long‐term overall survival for heavily pretreated multiple myeloma patients with a favorable safety profile. Carfilzomib monotherapy can be a good option for heavily pretreated multiple myeloma patients. This multicenter, open‐label phase 1/2 study evaluated single‐agent carfilzomib in 50 heavily pretreated Japanese patients with relapsed/refractory multiple myeloma (in phase 1, patients were dosed at three levels: 15, 20, or 20/27 mg/m2; in phase 2, patients were treated with 20/27 mg/m2 carfilzomib). Median duration of exposure to carfilzomib in the 20/27 mg/m2 group at this final analysis was 4.7 months (range: 0.3‐39.4) and the overall response rate in the 20/27 mg/m2 group, the primary endpoint of the study, was 22.5% (n = 9) (95% confidence interval, 12.3‐37.5) with 2.5% (n = 1) stringent complete response. Giving long‐term carfilzomib monotherapy led to long‐term overall survival for heavily pretreated multiple myeloma patients with a favorable safety profile.