演題詳細

一般口演 / Oral Session

一般口演 86 (Oral Session 86) :骨髄腫:再発難治・治療

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日程
2013年10月13日(日)
時間
08:45 - 09:45
会場
第10会場 / Room No.10 (ロイトン札幌 20F パールホールAB)
座長・司会
伊藤 薫樹 (Shigeki Ito):1
1:岩手医科大学 血液・腫瘍内科
 
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Dose-escalation study of CPM in combination with BTZ and DEX (CBD) for relapsed/refractory MM

演題番号 : OS-3-71

寺部 里美 (Satomi Terabe):1、木下 朝博 (Tomohiro Kinoshita):2、山本 一仁 (Kazuhito Yamamoto):3、澤 正史 (Masashi Sawa):4、小澤 幸泰 (Yukiyasu Ozawa):5、熱田 由子 (Yoshiko Atsuta):6、鈴木 律郎 (Ritsuro Suzuki):6、杉浦 勇 (Isamu Sugiura):1

1:Div. Hem./Oncology, Toyohashi Municipal Hospital, Toyohashi, Japan、2:Dep. Hem., Nagoya Univ. Grad. Sch. of Med., Nagoya, Japan、3:Dep. Hem. Cell Ther., Aichi Cancer Center Hospital, Nagoya, Japan、4:Dep. Hem., Anjo Kosei Hospital, Anjo, Japan、5:Dep. Hem., Japanese Red Cross Nagoya First Hospital, Nagoya, Japan、6:Dep. Hem. Stem Cell Trans. Data Manage./Biost., Nagoya Univ. Grad. Sch. Med., Nagoya, Japan

 

Purpose: This study (UMIN000001347) was conducted to evaluate the safety and efficacy and to determine the recommended dose (RD) of CPM in CBD, a combination of cyclophosphamide(CPM) with bortezomib (BTZ) and high-dose dexamethasone (DEX) for patients(pts) with relapsed or refractory multiple myeloma (MM). Patients and Methods: Pts were enrolled to receive 3 cycles of BTZ 1.3 mg/m2 on days 1, 4, 8, and 11 in combination with DEX 20 mg/m2 on the day of BTZ and the day thereafter. Pts received CPM (iv) on day 1 and 8 at either 3 dose levels; 300 -, 400 - or 500 mg/m2, escalating by 3+3 design. The RD was defined in the first cycle. The feasibility in the 2nd and 3rd cycles, as well as the efficacy and toxicity after 3 cycles were also assessed. Results: Six, three, and six eligible pts were assigned to each 3 levels. The RD of CPM was 500 mg/m2. DLTs were seen in 2 pts, one in level 1 with increased γ-GTP and one in level 3 with increased γ-GTP and concomitant increased ALT. Both pts recovered from DLT without any supportive care. Therapy-related mortality, severe adverse events including pneumonitis, infection and peripheral neuropathy were not reported during the 2nd and 3rd courses. In total, 2 (13.3%), 1 (6.7%) and 8 (53.3%) pts achieved CR, VGPR and PR, respectively. Conclusion: The RD of CPM in CBD regimen was 500 mg/m2. The CBD was well tolerated and showed promising activity in relapsed or refractory MM pts. The efficacy and toxicity of CBD as an induction regimen prior to high-dose therapy has been investigated in the phase II study (UMIN000008399) by Nagoya BMTG.

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