Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial. Issue 1 (31st December 2022)

• Record Type: Journal Article
• Authors: Muranushi, Hiroyuki; Kanda, Junya; Kobayashi, Masayuki; Maeda, Takeshi; Kitano, Toshiyuki; Tsuji, Masaaki; Ueda, Yasunori; Ishikawa, Takayuki; Nohgawa, Masaharu; Watanabe, Mitsumasa; Imada, Kazunori; Moriguchi, Toshinori; Itoh, Mitsuru; Ohno, Hitoshi; Yonezawa, Akihito; Hirata, Hirokazu; Arima, Nobuyoshi; Asagoe, Kohsuke; Anzai, Naoyuki; Nagata, Kayoko; Yasuno, Shinji; Kuwabara, Yoshihiro; Kitao, Hiromi; Kim, Ihhwa; Kawagishi, Kiyomi; Ueshima, Kenji; Tominari, Shinjiro; Nakayama, Takeo; Yamashita, Kouhei; Takaori-Kondo, Akifumi
• Is Part Of: Hematology. Volume 27:Issue 1(2022)
• Page Start: 239
• Page End: 248
• Publication Date: 2022-12-31
• Subjects: Multiple myeloma -- bortezomib -- cyclophosphamide -- autologous stem cell transplantation -- induction therapy -- consolidation therapy -- maintenance therapy -- Japan; Blood -- Diseases -- Periodicals; Hematology -- Periodicals; Blood -- Transfusion -- Periodicals; 616.15005
• DOI: 10.1080/16078454.2022.2032915
• Languages: English
• ISSNs: 1024-5332

Abstract

ABSTRACT: Objectives: We conducted a phase II trial to prospectively evaluate the efficacy and safety of bortezomib-cyclophosphamide-dexamethasone (VCD) induction, autologous stem cell transplantation (ASCT), VCD consolidation, and bortezomib maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients in Japan (UMIN000010542). Methods: From 2013 to 2016, 42 patients with a median age of 58 (range 42–65) years with NDMM were enrolled in 15 centers. The primary endpoint was the complete response (CR) /stringent CR (sCR) rate after transplantation, and overall/progression-free survival rates were also evaluated. Results: Following induction therapy, the overall response rate was obtained in 71% of patients, including a CR/sCR of 10% and a very good partial response (VGPR) of 26%. Twenty-six of the 42 patients completed ASCT following the protocol and CR/sCR and VGPR rate 100 days after ASCT was 26% and 17%, respectively. During consolidation therapy, 3 of the 24 patients achieved deeper responses. Eight of the 18 patients completed 2-year bortezomib maintenance without disease progression and grade 3/4 toxicities. Five patients were VGPR or partial response after ASCT but maintained response with 2-year bortezomib maintenance. Two-year overall and progression-free survival rates were 92.5% (95% confidence interval [CI]: 78.5%−97.5%) and 62.6% (95% CI: 45.8%−75.5%), respectively. Grade 3/4 toxicities (≥ 10%) included neutropenia (19%) and anemia (17%) in induction, and thrombocytopenia (29%) in consolidation. Conclusion: VCD induction/consolidation and bortezomib maintenance with ASCT for NDMM resulted in a high CR/sCR rate and provided good overall/progression-free survival in Japan.