16 results
Primary objectives:- to assess the safety and tolerability of a single ascending intravenous (IV) infusion doses of the research medication.- to determine the maximum tolerated dose (MTD) of IV infusion doses of the research medication.Secundary…
We hypothesize that online adaptation or individualization of the population PKPD model of propofol will decrease the residual error between predicted and measured plasma-concentrations during maintenance of anaesthesia, when the adapted PKPD models…
Answering the following questions:1. Main question: Is remifentanil a usefull medication for PSA in the emergency department?2. What is the recovery time of the patient when using fentanyl / propofol / remifentanil (time between last gift PSA…
The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be…
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with propofol and daily sedation stops, in maintaining a target depth of sedation in ventilated…
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…
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…
Evaluation of the effect of daratumumab in combination with ATRA in patients with relapsed/refractory multiple myeloma
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 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…
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…
Primary:* * To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy…
Study Objective(s):Primary-To compare the overall survival (OS) of subjects with locally advanced or metastatic urothelialcancer treated with enfortumab vedotin (EV) to the OS of subjects treated with chemotherapySecondary-To compare progression-…
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 compare the efficacy of teclistamab and talquetamab both in combination with daratumumab and lenalidomide (Tec-DR and Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).