Efficacy and Safety of a Weekly Cyclophosphamide-Bortezomib-Dexamethasone Regimen as Induction Therapy Prior to Autologous Stem Cell Transplantation in Japanese Patients with Newly Diagnosed Multiple Myeloma: A Phase 2 Multicenter Trial

Autor: Junichi Mukae, Takuya Komeno, Noriko Doki, Keisuke Tanaka, Atsushi Shinagawa, Takeshi Kobayashi, Kazuteru Ohashi, Takashi Kumagai, Megumi Akiyama, Naoki Wakimoto, Hiroshi Kojima, Daisuke Kudo, Shigeo Toyota, Yuichi Nakamura, Koh Yamamoto, Kazuhiko Kakihana, Tatsuya Saito, Hina Takano, Mitsuo Hori, Yuho Najima, Chikashi Yoshida, Masahide Yamamoto, Ikuyo Tsutsumi, Yasushi Okoshi, Takayuki Fujio, Aiko Igarashi
Rok vydání: 2019
Předmět:
Zdroj: Acta Haematologica. 141:111-118
ISSN: 1421-9662
0001-5792
DOI: 10.1159/000495338
Popis: We assessed the efficacy and safety of weekly cyclophosphamide-bortezomib-dexamethasone (CBD) induction prior to autologous stem cell transplantation (ASCT) in newly diagnosed Japanese patients with multiple myeloma (MM). This regimen consisted of four 28-day cycles of once-weekly oral cyclophosphamide (300 mg/m2), subcutaneous bortezomib (1.3 mg/m2), and oral dexamethasone (40 mg). Responding patients underwent stem cell collection followed by ASCT. The primary endpoint was the postinduction rate of achieving a near complete response (nCR) or better. Among the 38 enrolled patients, a complete response (CR), an nCR, a very good partial response (VGPR), and a partial response (PR) were achieved in 10.5, 2.6, 23.7, and 36.8% of cases, respectively. A grade 4 hematological adverse event (AE) was observed in 1 patient. Grade 3–4 infection, including febrile neutropenia, was observed in 4 patients (10.5%). Although 2 patients dropped out due to AE, 94.7% of the patients completed the induction phase. However, because of a poor response to induction chemotherapy (
Databáze: OpenAIRE