20 results
The primary objective of this study is to evaluate the blood pressure control rate after 12 weeks of treatment with telmisartan/amlodipine FDC in patients who were previously not controlled on RAAS blocking mono-therapy (ARBs, ACEi, DRI).
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
To decrease the cumulative incidence of (hematological) relapse
The purpose of this study is to see if Daratumumab is useful for treating patients with relapsed or refractory Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), or Follicular Lymphoma (FL). Another purpose of the study is to see if…
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…
The primary objective of the main non-inferiority study is to determine the safety of TACmono starting nine months after kidney transplantation in immunologically low-risk patients in terms of BPAR-rate 15 months after transplantation compared to…
Evaluation of the effect of daratumumab in combination with ATRA in patients with relapsed/refractory multiple myeloma
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
Primary Objectives- To evaluate the pharmacokinetics and safety of the Dara-MD SC delivery of daratumumab (Part 1).- To evaluate the pharmacokinetics and safety of the Dara-CF SC delivery of daratumumab (Part 2).-To evaluate the safety of Dara-CF…
The primary objective is to determine if the addition of daratumumab to VRd will prolong PFS defined as the time from the date of randomization to the date of disease progression (assessed by International Myeloma Working Group [IMWG] criteria) or…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in…
Primary objective:To compare the efficacy of iberdomide, daratumumab and dexamethasone (IberDd) to that of daratumumab, bortezomib and dexamethasone (DVd) in terms of progression-free survival (PFS) in subjects with RRMMSecondary objectives:• In…
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
Primary Objective- To evaluate if daratumumab can effectively decrease M protein in subjects with intermediate or high-risk SMM as assessed by CR rate- To determine if daratumumab reduces the progression/death rate in subjects with intermediate or…
Safety: To assess the safety and tolerability of BMS-986165 in LNEfficacy: Efficacy: To evaluate the efficacy of BMS 986165 compared with placebo with regard to proteinuria SecondaryEfficacy - To evaluate the efficacy of BMS-986165 with regard to…
The purpose of this study is to compare the efficacy of teclistamab and talquetamab both in combination with daratumumab and lenalidomide (Tec-DR and Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).