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).

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.

• Authors: 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 Sugiura, Junya Kuroda, Toshihiro Miyamoto, Michinori Ogura, Kensei Tobinai, Yuzuru Kanakura, Tomomitsu Hotta
• Journal: [Rinsho ketsueki] The Japanese journal of clinical hematology (Rinsho Ketsueki) Vol. 57 Issue 11 Pg. 2311-2318 ( 2016) ISSN: 0485-1439 [Print] Japan
• PMID: 27941278 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Bortezomib
• Prednisolone
• Melphalan

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bortezomib
• Female
• Follow-Up Studies
• Humans
• Male
• Melphalan (administration & dosage)
• Middle Aged
• Multiple Myeloma (drug therapy)
• Prednisolone (administration & dosage)
• Time Factors
• Treatment Outcome