36 results
Evaluation of the effect of salvage therapy with R-DHAP followed by reduced-intensity conditioning and allogeneic stem cell transplantation from a sibling or unrelated donor
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…
PrimaryTo assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are* with t(4;14)…
The objective of this study is to test the hypothesis that in patients with inflammatory neuropathies and conduction blocks, corticosteroid treatment leads to:1. Hyperpolarization and reduced excitability of motor axons. 2. An increase of the number…
To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
(1) Determination of the effect of dexamethasone on the biodistribution and kinetics of [11C]TMZ in GBM patients. (2) The effect of DXM on CBF. If there is an effect of DXM on CBF: (3) The effect of blood flow in the brain on [11C]TMZ uptake.
To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs PFS in subjects receiving Rd alone.
To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.
1. Standardized reporting of occurrence of metabolic adverse events after treatment with glucocorticoid pulse therapy in chronic rheumatoid arthritis patients (who have exacerbation of disease).2. Determing if metabolic adverse events due to…
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 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…
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.
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…
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…
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…
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 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:…
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…
* To establish the safety profile of daratumumab when given in combination with lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory MM