52 results
Aim of the studyTo study the effectiveness and toxicity of dexamethasone to prevent the occurrence of a pain flare after short schedule radiotherapy for painful bone metastases and to define the optimal schedule of dosing.Research questions:1. What…
Primary: To determine the optimal dose/recommended dose (RD) of pre-medication dexamethasone around docetaxel infusion.Secondary: * Does a dose reduction of prophylactic dexamethasone around the docetaxel infusion decrease the body*s metabolic…
We plan to conduct a large, pragmatic, multicentre, randomised non-inferiority trial to determine whether the use of intraoperative dexamethasone, a widely used antiemetic in perioperative medicine, is associated with an unacceptable increased risk…
* To establish the safety profile of daratumumab when given in combination with lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory MM
Primary Objective(s)Phase I (completed)The primary objective of the Phase I portion of the study is to determine the maximum tolerated dose (MTD) of the combination of melflufen and dexamethasone in patients with relapsed/refractory multiple myeloma…
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…
Primary Objective: Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone (LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.Secondary Objectives:- Analyze the population…
Primary ObjectiveThe primary objective is to compare the efficacy of daratumumab when combined with VELCADE (bortezomib) and dexamethasone (DVd) to that of VELCADE and dexamethasone (Vd), in terms of progression-free survival (PFS) in subjects with…
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
Primary Objective:- Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma and impaired renal function.Secondary Objectives:- Evaluate renal efficacy of the…
The primary objective of the study is to evaluate if rovalpituzumab tesirine improves progression-free and overall survival in subjects with extensive-stage SCLC who have ongoing clinical benefit (SD, PR, or CR) following the completion of 4 cycles…
This study aims to re-examine the bioequivalence of prednisolone and dexamethasone at two different doses by assessing tissue specific glucocorticoids effects, including the immune system, brain functioning, hormonal axes, and renal parameters.
To determine whether polystyrene sulfonate has an effect on exposure of amitriptyline, when taken simultaneously, compared to amitriptyline taken alone in healthy volunteers, expressed in Cmax and AUC0-8h.
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.
The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide, bortezomib, and dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B:…
To evaluate the (cost)effectiveness and safety of early dexamethasone treatment in preventing hospital admission or death and reducing disease severity in patients who are monitored after a GP consultation for deteriorating COVID-19. Because the…
The safety and efficacy of JNJ-68284528 in heavily pretreated patients with multiple myeloma is being evaluated in the Phase 1b/2 Study 68284528MMY2001. As the degree of benefit of the CAR-T therapy is dependent on a patient*s immune response, JNJ-…
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 objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).
The primary objective of this study is to compare the efficacy of teclistamab monotherapy (Arm A) with that of an investigator*s choice of PVd or Kd (Arm B: termed PVd/Kd hereafter) as assessed by PFS.