Bortezomib-cyclophosphamide-dexamethasone induction/consolidation and bortezomib maintenance for transplant-eligible newly diagnosed multiple myeloma: phase 2 multicenter trial

Hematology

Hiroyuki Muranushi¹  Masayuki Kobayashi¹  Kayoko Nagata¹  Kouhei Yamashita¹  Junya Kanda¹  Akifumi Takaori-Kondo¹  Mitsumasa Watanabe²  Kazunori Imada³  Masaharu Nohgawa⁴  Hirokazu Hirata⁵  Takayuki Ishikawa⁶  Akihito Yonezawa⁷  Takeshi Maeda⁸  Yasunori Ueda⁸  Mitsuru Itoh⁹  Kiyomi Kawagishi^1,10  Kenji Ueshima^1,10  Ihhwa Kim^1,10  Hiromi Kitao^1,10  Takeo Nakayama^1,11  Shinjiro Tominari^1,11  Toshinori Moriguchi^1,12  Toshiyuki Kitano^1,13  Nobuyoshi Arima^1,13  Yoshihiro Kuwabara^1,14  Masaaki Tsuji^1,15  Kohsuke Asagoe^1,16  Naoyuki Anzai^1,17  Hitoshi Ohno^1,18  Shinji Yasuno^1,19 

[1] Graduate School of Medicine;Hyogo Prefectural Amagasaki General Medical Center;Japanese Red Cross Osaka Hospital;Japanese Red Cross Society Wakayama Medical Center;Kansai Electric Power Hospital;Kobe City Hospital Organization Kobe City Medical Center General Hospital;Kokura Memorial Hospital;Kurashiki Central Hospital;Kyoto City Hospital;Kyoto University Hospital;Kyoto University School of Public Health;Kyoto-Katsura Hospital;Medical Research Institute Kitano Hospital;Osaka International Cancer Institute;Otsu Red Cross Hospital;Shiga General Hospital;Takatsuki Red Cross Hospital;Tenri Hospital;The Jikei University School of Medicine;

关键词: multiple myeloma;    bortezomib;    cyclophosphamide;    autologous stem cell transplantation;    induction therapy;    consolidation therapy;    maintenance therapy;    japan;   

DOI  :  10.1080/16078454.2022.2032915

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown