SNPMiner Trials (Home Page)
Report for Mutation G21210A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 3 clinical trials
Clinical Trials
1 Aspirin After Six Months or One Year of Oral Anticoagulants for the Prevention of Recurrent Venous Thromboembolism in Patients With Idiopathic Venous Thromboembolism. The WARFASA Study.
To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism
NCT00222677 Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolism Atherosclerosis Drug: aspirin MeSH:Pulmonary Embolism Thrombosis Atherosclerosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis
HPO:Atherosclerosis Deep venous thrombosis Pulmonary embolism Thromboembolism Type IV atherosclerotic lesion Venous thrombosis
Exclusion Criteria: - permanent risk factors for venous thromboembolism: patients known to have antiphospholipid antibodies or lupus anticoagulant (based on local laboratory criteria) or to have homozygous factor V Leiden or homozygous prothrombin G21210A or heterozygous factor V Leiden plus heterozygous prothrombin G21210A or antithrombin III deficiency; patients with active malignancy - temporary risk factors for venous thromboembolism - any recurrence of venous thromboembolism or bleeding episode during the established 6-month period of oral anticoagulant treatment - allergy or intolerance of aspirin - clear indication for aspirin or other anti-platelet therapy (e.g. --- G21210A ---
Exclusion Criteria: - permanent risk factors for venous thromboembolism: patients known to have antiphospholipid antibodies or lupus anticoagulant (based on local laboratory criteria) or to have homozygous factor V Leiden or homozygous prothrombin G21210A or heterozygous factor V Leiden plus heterozygous prothrombin G21210A or antithrombin III deficiency; patients with active malignancy - temporary risk factors for venous thromboembolism - any recurrence of venous thromboembolism or bleeding episode during the established 6-month period of oral anticoagulant treatment - allergy or intolerance of aspirin - clear indication for aspirin or other anti-platelet therapy (e.g. --- G21210A --- --- G21210A ---
Primary Outcomes
Measure: recurrence of VTE and/or VTE related death Time: at least 24 months per patientSecondary Outcomes
Measure: recurrent VTE+ death; cardiovascular events, bleeding events, critical ischemia of the lower limbs, mesenteric infarction, all cause mortality and newly diagnosed cancer Time: at least 24 months per patient2 An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits. The plasma cells can be killed and their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide, steroids, such as dexamethasone, and drugs that stimulate the immune system, such as lenalidomide. The present trial studies the efficacy and safety of the combination of cyclophosphamide, lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated and need further therapy.
NCT00607581 Amyloidosis Drug: cyclophosphamide Drug: lenalidomide Drug: dexamethasone MeSH:Immunoglobulin Light-chain Amyloidosis Amyloidosis
HPO:Amyloidosis
Prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency. --- G21210A ---
Primary Outcomes
Measure: hematologic response rate Time: at 3 monthsSecondary Outcomes
Measure: organ response rate Time: at 3 monthsMeasure: time to response Time: every 28 days
Measure: time to progression Time: every 3 months for 3 years
Measure: survival Time: up to 3 years after treatment discontinuation
Measure: toxicity Time: continuous during treatment
3 A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation
Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.
NCT01134484 Multiple Myeloma Drug: Velcade Drug: Thalidomide Drug: Dexamethasone Procedure: Peripheral Blood Stem Cell (PBSC) collection Procedure: First Autologous Transplantation Procedure: Second Autologous Transplantation MeSH:Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma
- Patient has a previous diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency. --- G21210A ---
Primary Outcomes
Description: Responses to induction therapy were reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive) and very good partial response (VGPR) (at least 90% serum and urine M-protein reduction) categories. Comparisons of response rates between treatment arms are performed using Fisher's exact test.
Measure: Rate of CR+nCR to induction treatment Time: 63 days after the start day of either TD or VTD as induction therapySecondary Outcomes
Description: Responses to autotransplantation(s) and consolidation therapy were reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the EBMT, with the addition of nCR and VGPR categories. Comparisons of response rates between treatment arms are performed using Fisher's exact test. Comparisons of response rates between treatment arms are performed using Fisher's exact test.
Measure: Rate of CR+nCR to autotransplantation(s) and subsequent consolidation therapy Time: 90 days after the second autologous transplantation and 70 days after the beginning of either TD or VTD as consolidation therapyDescription: TTP is defined as time from start of induction treatment with either TD or VTD to relapse or progression, as evaluated according to EBMT criteria. Comparison of TTP between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Measure: Time To Progression (TTP) Time: Average time period between the start day of either TD or VTD as induction therapy and the day of relapse or progressionDescription: PFS is defined as time from start of treatment to progression/relapse, or death, whichever occurs firstly. Comparison of PFS between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Measure: Progression-Free Survival (PFS) Time: Average time period between the start day of either TD or VTD as induction therapy and the day of relapse or progression or death, whichever occurs firstlyDescription: OS is defined as time from start of treatment to death. Comparison of OS between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Measure: Overall Survival (OS) Time: Average time period between the start day of either TD or VTD as induction therapy and the day of death, due to any causeDescription: Safety is monitored until 30 days after the last dose of study drug. Toxicities are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Rates of adverse events are compared between treatment arms using the chi-square test.
Measure: Safety Time: Average time period between the start day of either TD or VTD as induction therapy and the day of any toxicity/adverse event(s) recorded during and after study drug administration