Cyclophosphamide, Bortezomib, dexamethasone
( DrugBank: Cyclophosphamide / KEGG DRUG: Cyclophosphamide, Cyclophosphamide )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 28 | 全身性アミロイドーシス | 6 |
28. 全身性アミロイドーシス
臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
Showing 1 to 6 of 6 trials
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2031220037 (jRCT2031220037) | 20/06/202220220620 | 23/04/202220220423 | A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloido ... | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis - AFFIRM-AL A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of B ... | Light Chain (AL) Amyloidosis | - Birtamimab group: Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy - Placebo group: Intravenous 0.9% Saline administration as a placebo every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy - Birtamimab group: Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-conta ... | Nie Christie | NULL | Recruiting | >= 18age old | Not applicable | Both | 16 | Phase 3 | Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic of Korea;Netherlands;New Zealand;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;United States;Japan Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic ... |
| 2 | NCT04504825 (ClinicalTrials.gov) | February 2, 202120210202 | 20/7/202020200720 | A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloido ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasm ... | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen | Alexion | NULL | Recruiting | 18 Years | N/A | All | 124 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Switzerland;United Kingdom United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Jap ... |
| 3 | NCT04512235 (ClinicalTrials.gov) | November 12, 202020201112 | 10/8/202020200810 | A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloido ... | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasm ... | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen | Alexion | NULL | Recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Jap ... |
| 4 | NCT04304144 (ClinicalTrials.gov) | March 18, 202020200318 | 28/2/202020200228 | A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tole ... | AL Amyloidosis | Drug: CAEL-101;Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: Daratumumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 5 | JPRN-JapicCTI-183929 | 17/7/201820180717 | 13/04/201820180413 | 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 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide,Bort ... | 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 A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cy ... | 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. Intervention name : Cyclophosphamide, Bortezomib, dexamethasoneplus Daratumumab INN of the interventi ... | Janssen Pharmaceutical K.K. | NULL | complete | 20 | BOTH | 370 | Phase 4 | Japan, Asia except Japan, North America, Europe | |
| 6 | NCT01072773 (ClinicalTrials.gov) | March 201020100300 | 17/2/201020100217 | Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis Bortezomib, Cyclophosphamide,and Dexamethasonein Treating Patients With Primary Systemic Light Chain ... | Phase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain Amyloidosis Phase II Study of Bortezomib,Cyclophosphamide and Dexamethasonein Patients With Primary Systemic Lig ... | Primary Systemic Amyloidosis | Drug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasone | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 2 | Phase 2 | United States |