41 results
Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…
To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs PFS in subjects receiving Rd alone.
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of Lenalidomide added to standard induction chemotherapy for AML and select the feasible dose level for part B of the study2. To assess in a randomized…
Our proposed randomized controlled trial is the first making this head-to-head comparison in a *real life* primary care setting in the Netherlands. The primary research question is: does a 12-week combination therapy of open label varenicline and…
To investigate the feasibility and efficacy of a maximum of 6 cycles of Chlorambucil with Rituximab plus Lenalidomide at the RDL.
Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…
To study the efficacy of low dose Lenalidomide maintenance combined with bortezomib treatment following non myeloablative Allo-SCT on Event Free Survival.
2.1 Primary objective * To determine the feasibility (as measured by non-relapse mortality after 7 months) of the regimen of Ibritumomab, followed by a reduced intensity, partial T cell-depleted allogeneic stem cell transplantation and…
The primary objective is to determine the safety and the maximum tolerated dose of dasatinib in combination with lenalidomide and low dose dexamethasone in subjects with relapsed or refractory multiple myeloma
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. The secondary objective is to…
This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…
This study is a Phase II, non-randomized, open label trial to evaluate Safety and Antiviral activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.
Phase I:-To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule.Phase II:-To…
Drug craving and impulsivity will be assessed with questionnaires, fMRI/EEG using cue-reactivity and impulsivity paradigms. Relapse will be assessed by checking urine samples every week.
To suppress low-level viremia to a level below 50cp/mL in patients using cART by switching their current non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI to DRV boosted with ritonavir (RTV) (DRV/r). Secondary objectives are to reduce the…
To determine if maintenance treatment with lenalidomide prolongs progression free survival in patients with advanced stage CTCL that has notbeen previously treated with intravenous chemotherapy except the chemotherapy received in the preceeding…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old