Cyclophosphamide, bortezomib, dexamethasone plus daratumumab (DrugBank: Bortezomib, Cyclophosphamide, Dexamethasone, Daratumumab)
44 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
11 | 重症筋無力症 | 0 |
13 | 多発性硬化症/視神経脊髄炎 | 0 |
14 | 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー | 0 |
16 | クロウ・深瀬症候群 | 0 |
19 | ライソゾーム病 | 0 |
20 | 副腎白質ジストロフィー | 0 |
26 | HTLV-1関連脊髄症 | 0 |
28 | 全身性アミロイドーシス | 1 |
35 | 天疱瘡 | 0 |
36 | 表皮水疱症 | 0 |
40 | 高安動脈炎 | 0 |
41 | 巨細胞性動脈炎 | 0 |
42 | 結節性多発動脈炎 | 0 |
43 | 顕微鏡的多発血管炎 | 0 |
44 | 多発血管炎性肉芽腫症 | 0 |
45 | 好酸球性多発血管炎性肉芽腫症 | 0 |
46 | 悪性関節リウマチ | 0 |
49 | 全身性エリテマトーデス | 0 |
50 | 皮膚筋炎/多発性筋炎 | 0 |
51 | 全身性強皮症 | 0 |
52 | 混合性結合組織病 | 0 |
56 | ベーチェット病 | 0 |
60 | 再生不良性貧血 | 0 |
62 | 発作性夜間ヘモグロビン尿症 | 0 |
65 | 原発性免疫不全症候群 | 0 |
66 | IgA腎症 | 0 |
84 | サルコイドーシス | 0 |
85 | 特発性間質性肺炎 | 0 |
93 | 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] | 0 |
96 | クローン病 | 0 |
162 | 類天疱瘡(後天性表皮水疱症を含む。) | 0 |
164 | 眼皮膚白皮症 | 0 |
172 | 低ホスファターゼ症 | 0 |
222 | 一次性ネフローゼ症候群 | 0 |
224 | 紫斑病性腎炎 | 0 |
256 | 筋型糖原病 | 0 |
265 | 脂肪萎縮症 | 0 |
274 | 骨形成不全症 | 0 |
283 | 後天性赤芽球癆 | 0 |
284 | ダイアモンド・ブラックファン貧血 | 0 |
285 | ファンコニ貧血 | 0 |
288 | 自己免疫性後天性凝固因子欠乏症[自己免疫性出血病XIII (~2017.3)] | 0 |
326 | 大理石骨病 | 0 |
331 | 特発性多中心性キャッスルマン病 | 0 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | JPRN-JapicCTI-183929 | 17/7/2018 | 13/04/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | Amyloidosis | Intervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab INN of the intervention : - Dosage And administration of the intervention : Participants will receive dexamethasone (20mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years. Control intervention name : Cyclophosphamide, Bortezomib, dexamethasone INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive dexamethasone (40milligrams [mg] orally or intravenous [IV]dose), followed by cyclophosphamide (300milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. | Janssen Pharmaceutical K.K. | NULL | complete | 20 | BOTH | 370 | Phase 3 | Japan, Asia except Japan, North America, Europe |