治療に抵抗する多発性骨髄腫 (SIRIUS) の患者に対するダラトゥムマブ単独治療:オープンランドマイズされた第2相試験
Sagar Lonial1, Brendan M Weiss2, Saad Z Usmani3
1Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Lancet (London, England)
|January 19, 2016
まとめ
耐火性多発性骨髄腫の患者では,ダラトゥムマブ単独療法が推奨される効果を示し,安全性プロファイルが良好であった. この新種のCD38標的抗体は 治療前の重症患者にとって 新しい希望をもたらします
科学分野:
- 血液学
- 腫瘍学
- 免疫療法
背景:
- タンパク質阻害剤や免疫調節薬に耐性のある多発性骨髄腫患者は,新しい治療法が必要である.
- CD38を標的とするモノクローナル抗体であるダラトゥムマブは,この患者集団における有効性を調査した.
研究 の 目的:
- 再発性または耐性多発性骨髄腫患者のダラトゥムマブ単独治療の有効性と安全性を評価する.
- 臨床試験におけるダラトゥムマブの最適な用量を決定する.
主な方法:
- 耐火性多発性骨髄腫の患者を対象としたオープン・マルチセンターフェーズ2試験です.
- 患者はランダムに分けられ,静脈内投与ダラトゥムマブを8 mg/ kgまたは16 mg/ kgで投与された.
- 主要評価項目は総合反応率 (ORR) でした.
主要な成果:
- 16 mg/ kgのダラトゥムマブを投与した106人の患者では,ORRは29. 2% (95% CI 20. 8~38. 9) であった.
- 治療応答の期間中位は7. 4ヶ月,中位は3. 7ヶ月でした.
- ダラトゥムマブはよく耐えられ,疲労と貧血が最も一般的な副作用であり,副作用による治療中止は報告されなかった.
結論:
- ダラトゥムマブ単独治療は,重度の前治療および耐性多発性骨髄腫の患者で有望な効果を示した.
- この薬は,この困難な患者集団において,好ましい安全性プロファイルを示した.
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