32 results
Objective: The response over time on daytime alertness and performance will be assessed following a single oral dose of bilastine 20 mg in healthy volunteers performing flying ability tests in a hypobaric chamber with an ambient pressure of 75.2 kPa…
To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
To objective the most efficacy way to ripening the cervix of pregnant women.
To assess in term pregnant women with an unfavourable cervix (Bishop score < 6, Appendix1) the effectiveness of induction of labour with a transcervical Foley catheter as compared to induction with prostaglandins.
The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…
The purpose of this study is to see if Daratumumab is useful for treating patients with relapsed or refractory Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), or Follicular Lymphoma (FL). Another purpose of the study is to see if…
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:…
Primary Objectives- To evaluate the pharmacokinetics and safety of the Dara-MD SC delivery of daratumumab (Part 1).- To evaluate the pharmacokinetics and safety of the Dara-CF SC delivery of daratumumab (Part 2).-To evaluate the safety of Dara-CF…
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…
Evaluation of the effect of nivolumab and daratumumab with or without low dose cyclophosphamide in patients with relapsed/refractory multiple myeloma
Primary Objective:• To evaluate the proportion of patients with a response of very good partial response (VGPR) or better to IDd treatment.Secondary Objectives:• To measure progression-free survival (PFS), time to progression (TTP), and overall…
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
* To establish the safety profile of daratumumab when given in combination with lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory MM
Evaluation of the effect of daratumumab in combination with ATRA in patients with relapsed/refractory multiple myeloma
Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in…
Primary objective:-To compare the efficacy of elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C) as measured by PFS-To compare the efficacy of elranatamab + daratumumab (Arm B) vs. Arm C.- To assess the safety and tolerability…
Primary:To compare the efficacy of BM in combination with BOR/DEX with that of daratumumab in combination with BOR/DEX in participants with RRMMSecondary:Other efficacy outcomes. Safety and tolerability. PK. Anti-drug antibodies. Questionnaires (…
The primary hypothesis of this study is that the 6-month OS rate of patients with newly diagnosed stage 3B AL amyloidosis will exceed 50% after primary therapy with daratumumab
Primary Objective- To evaluate if daratumumab can effectively decrease M protein in subjects with intermediate or high-risk SMM as assessed by CR rate- To determine if daratumumab reduces the progression/death rate in subjects with intermediate or…