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

print

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
 
前へ戻る

A phase I study of an anti-IL-6 mAb, siltuximab, in relapsed/refractory multiple myeloma (R/R MM)

演題番号 : OS-3-72

鈴木 達也 (Tatsuya Suzuki):1、小椋 美知則 (Michinori Ogura):1、鈴木 憲史 (Kenshi Suzuki):2、飛内 賢正 (Kensei Tobinai):3、安藤 潔 (Kiyoshi Ando):4、谷脇 雅史 (Masafumi Taniwaki):5、飯塚 拡応 (Koho Iizuka):6

1:Dept. Hem. & Onc., Nagoya Daini Red Cross Hosp., Nagoya, Japan、2:Dept. of Hem., Japanese Red Cross Med. Ctr., Tokyo, Japan、3:Dept. of Hem., Natl. Cancer Ctr. Hosp., Tokyo, Japan、4:Dept. of Hem. & Onc., Tokai U. School of Med., Isehara, Japan、5:Dept. of Hem.., Kyoto Pref. U. of Med., Kyoto, Japan、6:Oncology Dept., R&D, Janssen Pharma, K.K., Tokyo, Japan

 

[Purpose] Inhibition of IL-6 signaling has been shown to enhance the anti-tumor activity of proteasome inhibitors in MM cells in vitro. Siltuximab is an anti-IL-6 chimeric monoclonal antibody that neutralizes human IL-6. In this phase 1, non-randomized, open-label, dose-escalation study, we assessed the safety, tolerability, and preliminary efficacy of siltuximab with bortezomib (Bor) and dexamethasone (Dexa) in patients (pts) with R/R MM. [Patients and Methods] Siltuximab was given at 5.5 or 11.0 mg/kg IV on Day 1 of a 21-day cycle until disease progression. Bor was given IV at 1.3 mg/m2 on Day 1, 4, 8 and 11, and oral Dexa was given at 20 mg on Day 1, 2, 4, 5, 8, 9, 11, and 12. The dose-limiting toxicity (DLT) evaluation period was defined as Cycle 1. Response was evaluated every even-numbered cycle using the European Group for Blood and Marrow Transplantation criteria.[Results] As of data cutoff on May 21, 2012, 9 pts, 3 at 5.5 mg/kg siltuximab and 6 at 11.0 mg/kg, had received treatment. No DLTs were observed. The most common adverse event (AE) was thrombocytopenia; AEs >= grade 3 occurred in all pts. There were 3 severe AEs: pneumonia (5.5 mg/kg), allergic alveolitis (11 mg/kg), and interstitial lung disease (11 mg/kg). These 3 pts and one other who developed pneumonitis (11 mg/kg) discontinued the study. Complete response was observed in 2 pts, partial response in 4, and no change in 3. [Conclusion] Siltuximab at 5.5 and 11.0 mg/kg with Bor and Dexa was shown to be safe and tolerable and had preliminary efficacy in pts with R/R MM. Further investigation is needed.

前へ戻る