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Randomised phase II study to optimise melphalan, prednisolone, and bortezomib in untreated multiple myeloma (JCOG1105).
Maruyama, Dai; Iida, Shinsuke; Ogawa, Gakuto; Fukuhara, Noriko; Seo, Sachiko; Miyazaki, Kana; Yoshimitsu, Makoto; Kuroda, Junya; Tsukamoto, Norifumi; Tsujimura, Hideki; Hangaishi, Akira; Yamauchi, Takahiro; Utsumi, Takahiko; Mizuno, Ishikazu; Takamatsu, Yasushi; Nagata, Yasuyuki; Minauchi, Koichiro; Ohtsuka, Eiichi; Hanamura, Ichiro; Yoshida, Shinichiro; Yamasaki, Satoshi; Suehiro, Youko; Kamiyama, Yutaro; Tsukasaki, Kunihiro; Nagai, Hirokazu.
Afiliación
  • Maruyama D; Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
  • Iida S; Department of Hematology and Oncology, Nagoya City University Hospital, Nagoya, Japan.
  • Ogawa G; JCOG Data Center/Operating Office, National Cancer Center Hospital, Tokyo, Japan.
  • Fukuhara N; Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.
  • Seo S; Department of Hematology, National Cancer Center Hospital East, Kashiwa, Japan.
  • Miyazaki K; Department of Hematology and Oncology, Mie University School of Medicine, Tsu, Japan.
  • Yoshimitsu M; Department of Hematology and Rheumatology, Kagoshima University Hospital, Kagoshima, Japan.
  • Kuroda J; Division of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Tsukamoto N; Department of Hematology, Gunma University, Maebashi, Japan.
  • Tsujimura H; Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan.
  • Hangaishi A; Division of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.
  • Yamauchi T; Department of Hematology and Oncology, University of Fukui Hospital, Fukui, Japan.
  • Utsumi T; Department of Hematology, Shiga General Hospital, Moriyama, Japan.
  • Mizuno I; Division of Hematology, Hyogo Cancer Center, Akashi, Japan.
  • Takamatsu Y; Division of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan.
  • Nagata Y; Department of Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan.
  • Minauchi K; Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
  • Ohtsuka E; Department of Hematology, Oita Prefectural Hospital, Oita, Japan.
  • Hanamura I; Division of Hematology, Aichi Medical University, Nagakute, Japan.
  • Yoshida S; Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.
  • Yamasaki S; Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.
  • Suehiro Y; Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
  • Kamiyama Y; Department of Clinical Oncology and Hematology, The Jikei University Hospital, Tokyo, Japan.
  • Tsukasaki K; Department of Hematology, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Saitama, Japan.
  • Nagai H; Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Br J Haematol ; 192(3): 531-541, 2021 02.
Article en En | MEDLINE | ID: mdl-32583431
We conducted a randomised phase II study to determine the optimal dose and schedule of melphalan, prednisone, and bortezomib (MPB) (jRCTs031180097). Transplant-ineligible untreated multiple myeloma patients were randomised to Arm A (twice weekly bortezomib in one six-week cycle followed by eight five-week cycles of four times once weekly bortezomib with melphalan and prednisolone on days 1-4) or Arm B (nine four-week cycles of three times once weekly bortezomib with melphalan and prednisolone on days 1-4). The primary end-point was complete response (CR) rate. Of 91 patients randomised to two arms, 88 were eligible. The median cumulative bortezomib doses were 45·8 and 35·1 mg/m2 , CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR) 1·93 (95% CI 1·09-3·42)], respectively. Frequent grade ≥3 haematologic toxicities in Arms A and B were neutropenia (64·4% vs. 28·3%) and thrombocytopenia (35·6% vs. 10·9%). Grade 2/3 peripheral neuropathy was observed in 24·4/2·2% in Arm A and 8·7/0% in Arm B. In conclusion, Arm A was the more promising regimen, suggesting that the twice weekly schedule of bortezomib in the first cycle and higher cumulative dose of both bortezomib and melphalan influences the efficacy of modified MPB.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prednisolona / Protocolos de Quimioterapia Combinada Antineoplásica / Bortezomib / Melfalán / Mieloma Múltiple Tipo de estudio: Clinical_trials Límite: Aged / Aged80 / Female / Humans / Male Idioma: En Revista: Br J Haematol Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prednisolona / Protocolos de Quimioterapia Combinada Antineoplásica / Bortezomib / Melfalán / Mieloma Múltiple Tipo de estudio: Clinical_trials Límite: Aged / Aged80 / Female / Humans / Male Idioma: En Revista: Br J Haematol Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido