Cyclophosphamide, bortezomib, dexamethasone plus daratumumab (DrugBank: Bortezomib, Cyclophosphamide, Dexamethasone, Daratumumab)
25 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
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 |
28 | 全身性アミロイドーシス | 1 |
35 | 天疱瘡 | 0 |
46 | 悪性関節リウマチ | 0 |
53 | シェーグレン症候群 | 0 |
63 | 特発性血小板減少性紫斑病 | 0 |
64 | 血栓性血小板減少性紫斑病 | 0 |
65 | 原発性免疫不全症候群 | 0 |
70 | 広範脊柱管狭窄症 | 0 |
74 | 下垂体性PRL分泌亢進症 | 0 |
75 | クッシング病 | 0 |
81 | 先天性副腎皮質酵素欠損症 | 0 |
83 | アジソン病 | 0 |
84 | サルコイドーシス | 0 |
90 | 網膜色素変性症 | 0 |
96 | クローン病 | 0 |
97 | 潰瘍性大腸炎 | 0 |
162 | 類天疱瘡(後天性表皮水疱症を含む。) | 0 |
222 | 一次性ネフローゼ症候群 | 0 |
235 | 副甲状腺機能低下症 | 0 |
283 | 後天性赤芽球癆 | 0 |
296 | 胆道閉鎖症 | 0 |
299 | 嚢胞性線維症 | 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 |