34 results
This clinical trial will test the safety and performance of the Spinal Modulation Neurostimulator System in the treatment of chronic pain.Outcomes:Primary Outcomes: 1) Safety as determined by adverse event reporting2) Device performance as…
Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…
* To determine the efficacy of bortezomib plus dexamethasone induction therapy followed by HDM and auto-SCT in patients with newly diagnosed AL amyloidosis who are 18-70 years inclusive.* To asses the safety of bortezomib plus dexamethasone as…
The primary objective of the ERY-PAO study is to investigate the pharmacokinetics of acetylsalicylic acid (ASA) and omeprazole in morbidly obese subjects before and after RYGB surgery and to compare these data to study if there are differences in…
Evaluation of the safety and efficacy of bortezomib combined with cyclophosphamide and dexamethasone for induction and maintenance therapy.
Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…
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…
To study the efficacy of low dose Lenalidomide maintenance combined with bortezomib treatment following non myeloablative Allo-SCT on Event Free Survival.
To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
Primary objectives:Efficacy of bortezomib combined with DLI in patients with relapse myeloma following (non) myeloablative allo-SCT as measured by- response rate including percentage of complete remission according to EBMT criteria (appendix A)-…
The primary objective is to compare the overall response rate ORR(CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE tointravenously (IV) administered VELCADE in patients with previouslytreated multiple myeloma.The secondary…
To measure the effect of domperidone and omeprazole on reflux-time, duration, and symptoms of GERD
The primary objective of this study is:To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.Secondary objectives…
To assess the safety of treatment with escalating dosages of VELCADE in combination with ZARNESTRA in subjects with Intermediate-2 or high risk MDS according to the IPSS classification.
To find activity in this new class of drugs
Objective 1: To investigate the difference in prescribing proton pump inhibitors continuously rather than on demand in patient reported reflux symptoms, quality of life and self-rated health. Objective 2: To investigate whether the use of electronic…
Study ObjectivesTo compare the efficacy of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM Secondary Objectives:To evaluate the safety and additional efficacy of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with…
Primary: To assess best overall response rate (ORR) up to 8 cycles. Secondary: ORR, complete response (CR), very good partial response (VGPR), progression free survival (PFS), overall survival (OS), safety, PK, exposure-response (efficacy and safety…
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…