Long-term follow-up results of a phase I/II study of melphalan, prednisolone and bortezomib in Japanese transplant-ineligible multiple myeloma patients (JPN-102)

Daisuke Ogiya, Hirohiko Shibayama, Eiji Nakatani, Kiyoshi Ando, Kenshi Suzuki, Yoshiaki Kuroda, Toshiki Uchida, Dai Maruyama, Morio Matsumoto, Kosei Matsue, Shinsuke Iida, Yasuhito Terui, Masaki Ri, Takaaki Chou, Nobuyuki Aotsuka, Sumie Tabata, Jun Konishi, Kazuteru Ohashi, Atsushi Shinagawa, Isamu SugiuraJunya Kuroda, Toshihiro Miyamoto, Michinori Ogura, Kensei Tobinai, Yuzuru Kanakura, Tomomitsu Hotta

Research output: Contribution to journalArticle

Abstract

The phase I/II study of melphalan-prednisolone-bortezomib (MPB) therapy in Japanese patients with previously untreated multiple myeloma (MM) who are ineligible for hematopoietic stem cell transplantation (JPN-102 trial) (registered between July 2008 and March 2011) showed an overall response rate in the MPB arm equivalent to that of the VISTA trial. In this study, we followed up the clinical data of 92 of the 101 patients registered in the JPN-102 trial to clarify the long-term outcomes of MPB therapy. The median follow-up period was 50.8 (0.9-66.1) months. The median age of this cohort was 72 (48-84) years. The median progression-free survival was 25.7 (95%CI: 21.3-33.9) months and the overall survival rates at 1, 3 and 5 years were 98, 86 and 76%, respectively. There was no significant difference in either progression-free survival or overall survival when comparing a total bortezomib amount of 39 mg/m2 or more being administered versus less than 39 mg/m2. The outcomes of the JPN-102 cohort appeared, at a minimum, to not be inferior to those of the MPB cohort in the VISTA trial. A prospective trial is needed to establish the MPB regimen as being suitable for Japanese patients with multiple myeloma.

Original languageEnglish
Pages (from-to)2311-2318
Number of pages8
Journal[Rinsho ketsueki] The Japanese journal of clinical hematology
Volume57
Issue number11
Publication statusPublished - Jan 1 2016

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Melphalan
Prednisolone
Multiple Myeloma
Transplants
Disease-Free Survival
Hematopoietic Stem Cell Transplantation
Bortezomib
Arm
Survival Rate
Survival
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Long-term follow-up results of a phase I/II study of melphalan, prednisolone and bortezomib in Japanese transplant-ineligible multiple myeloma patients (JPN-102). / Ogiya, Daisuke; Shibayama, Hirohiko; Nakatani, Eiji; Ando, Kiyoshi; Suzuki, Kenshi; Kuroda, Yoshiaki; Uchida, Toshiki; Maruyama, Dai; Matsumoto, Morio; Matsue, Kosei; Iida, Shinsuke; Terui, Yasuhito; Ri, Masaki; Chou, Takaaki; Aotsuka, Nobuyuki; Tabata, Sumie; Konishi, Jun; Ohashi, Kazuteru; Shinagawa, Atsushi; Sugiura, Isamu; Kuroda, Junya; Miyamoto, Toshihiro; Ogura, Michinori; Tobinai, Kensei; Kanakura, Yuzuru; Hotta, Tomomitsu.

In: [Rinsho ketsueki] The Japanese journal of clinical hematology, Vol. 57, No. 11, 01.01.2016, p. 2311-2318.

Research output: Contribution to journalArticle

Ogiya, D, Shibayama, H, Nakatani, E, Ando, K, Suzuki, K, Kuroda, Y, Uchida, T, Maruyama, D, Matsumoto, M, Matsue, K, Iida, S, Terui, Y, Ri, M, Chou, T, Aotsuka, N, Tabata, S, Konishi, J, Ohashi, K, Shinagawa, A, Sugiura, I, Kuroda, J, Miyamoto, T, Ogura, M, Tobinai, K, Kanakura, Y & Hotta, T 2016, 'Long-term follow-up results of a phase I/II study of melphalan, prednisolone and bortezomib in Japanese transplant-ineligible multiple myeloma patients (JPN-102)', [Rinsho ketsueki] The Japanese journal of clinical hematology, vol. 57, no. 11, pp. 2311-2318.
Ogiya, Daisuke ; Shibayama, Hirohiko ; Nakatani, Eiji ; Ando, Kiyoshi ; Suzuki, Kenshi ; Kuroda, Yoshiaki ; Uchida, Toshiki ; Maruyama, Dai ; Matsumoto, Morio ; Matsue, Kosei ; Iida, Shinsuke ; Terui, Yasuhito ; Ri, Masaki ; Chou, Takaaki ; Aotsuka, Nobuyuki ; Tabata, Sumie ; Konishi, Jun ; Ohashi, Kazuteru ; Shinagawa, Atsushi ; Sugiura, Isamu ; Kuroda, Junya ; Miyamoto, Toshihiro ; Ogura, Michinori ; Tobinai, Kensei ; Kanakura, Yuzuru ; Hotta, Tomomitsu. / Long-term follow-up results of a phase I/II study of melphalan, prednisolone and bortezomib in Japanese transplant-ineligible multiple myeloma patients (JPN-102). In: [Rinsho ketsueki] The Japanese journal of clinical hematology. 2016 ; Vol. 57, No. 11. pp. 2311-2318.
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abstract = "The phase I/II study of melphalan-prednisolone-bortezomib (MPB) therapy in Japanese patients with previously untreated multiple myeloma (MM) who are ineligible for hematopoietic stem cell transplantation (JPN-102 trial) (registered between July 2008 and March 2011) showed an overall response rate in the MPB arm equivalent to that of the VISTA trial. In this study, we followed up the clinical data of 92 of the 101 patients registered in the JPN-102 trial to clarify the long-term outcomes of MPB therapy. The median follow-up period was 50.8 (0.9-66.1) months. The median age of this cohort was 72 (48-84) years. The median progression-free survival was 25.7 (95{\%}CI: 21.3-33.9) months and the overall survival rates at 1, 3 and 5 years were 98, 86 and 76{\%}, respectively. There was no significant difference in either progression-free survival or overall survival when comparing a total bortezomib amount of 39 mg/m2 or more being administered versus less than 39 mg/m2. The outcomes of the JPN-102 cohort appeared, at a minimum, to not be inferior to those of the MPB cohort in the VISTA trial. A prospective trial is needed to establish the MPB regimen as being suitable for Japanese patients with multiple myeloma.",
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AU - Ogiya, Daisuke

AU - Shibayama, Hirohiko

AU - Nakatani, Eiji

AU - Ando, Kiyoshi

AU - Suzuki, Kenshi

AU - Kuroda, Yoshiaki

AU - Uchida, Toshiki

AU - Maruyama, Dai

AU - Matsumoto, Morio

AU - Matsue, Kosei

AU - Iida, Shinsuke

AU - Terui, Yasuhito

AU - Ri, Masaki

AU - Chou, Takaaki

AU - Aotsuka, Nobuyuki

AU - Tabata, Sumie

AU - Konishi, Jun

AU - Ohashi, Kazuteru

AU - Shinagawa, Atsushi

AU - Sugiura, Isamu

AU - Kuroda, Junya

AU - Miyamoto, Toshihiro

AU - Ogura, Michinori

AU - Tobinai, Kensei

AU - Kanakura, Yuzuru

AU - Hotta, Tomomitsu

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