Phase I/II study of bortezomib‐melphalan‐prednisolone for previously untreated Japanese patients with multiple myeloma |
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| Authors: | Yoshiaki Ogawa Kenshi Suzuki Akira Sakai Shinsuke Iida Michinori Ogura Kensei Tobinai Morio Matsumoto Kosei Matsue Yasuhito Terui Kazuteru Ohashi Masami Ishii Harumi Y Mukai Kiyoshi Ando Tomomitsu Hotta |
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| Institution: | 1. Department of Hematology and Oncology, Tokai University School of Medicine, , Isehara, Japan;2. Department of Hematology, Japanese Red Cross Medical Center, , Tokyo, Japan;3. Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine (RIRBM), Hiroshima University, , Hiroshima, Japan;4. Department of Medical Oncology and Immunology, Nagoya City University Graduate School of Medical Sciences, , Nagoya, Japan;5. Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, , Nagoya, Japan;6. Department of Hematology and Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, , Tokyo, Japan;7. Department of Hematology, National Hospital Organization Nishigunma National Hospital, , Shibukawa, Japan;8. Division of Hematology/Oncology, Department of Medicine, Kameda Medical Center, , Kamogawa, Japan;9. Division of Medical Oncology/Hematology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, , Tokyo, Japan;10. Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, , Tokyo, Japan;11. Clinical Science Division, Janssen Pharmaceutical K.K., , Tokyo, Japan;12. Scientific Affairs Division, Janssen Pharmaceutical K.K., , Tokyo, Japan;13. National Hospital Organization Nagoya Medical Center, , Nagoya, Japan |
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| Abstract: | This phase I/II study was conducted to evaluate the safety and efficacy of bortezomib‐melphalan‐prednisolone in Japanese patients with previously untreated multiple myeloma who are ineligible for hematopoietic stem cell transplantation. One hundred and one patients were enrolled, and 99 patients received up to nine 6‐week cycles of bortezomib (0.7/1.0/1.3 mg/m2) on days 1, 4, 8, 11, 22, 25, 29, and 32 in cycles 1–4 and on days 1, 8, 22, and 29 in cycles 5–9, with melphalan (9 mg/m2) and prednisolone (60 mg/m2) on days 1–4 of each cycle. The recommended dose was determined in the phase I portion, and the overall response rate and safety of bortezomib‐melphalan‐prednisolone at the recommended dose were assessed in the phase II portion. The recommended dose of bortezomib was determined to be 1.3 mg/m2. Grade 3 or higher non‐hematological adverse events included diarrhea (12%) and peripheral neuropathy (10%); grade 4 hematological adverse events included lymphopenia (41%), neutropenia (30%), and thrombocytopenia (22%). Eleven patients had lung injury associated with bortezomib; two had grade 3 disease, and the other nine had grade 1 or 2 disease. Of the 86 patients treated with 1.3‐mg/m2 bortezomib in phases I and II, the median number of treatment cycles was 4.5, and the overall response rate was 70% (95% confidence interval: 59–79%). Bortezomib‐melphalan‐prednisolone with 1.3‐mg/m2 bortezomib was considered to be tolerable and effective in Japanese patients with previously untreated multiple myeloma. However, further investigation is needed to refine the administration schedule. |
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