10 results
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…
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…
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 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.
Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
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…