33 results
To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
The objectives are to evaluate:- The effect of Org 3236 on prostate volume compared to placebo;- The effect of Org 3236 on LUTS compared to placebo;- The effect of Org 3236 on urinary flow and postvoid residual volume compared toplacebo;- The effect…
Evaluation of the effect of daratumumab in combination with ATRA in patients with relapsed/refractory multiple myeloma
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…
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…
* 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:• 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…
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
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•…
Primary ObjectiveThe primary objective is to determine if the addition of daratumumab to VELCADE (bortezomib),Revlimid (lenalidomide), and dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd…
Primary objective* To determine the efficacy, defined as overall response rate (ORR; >= partial response (PR)), of 9 cycles of ixazomib, daratumumab and low dose dexamethasoneSecondary objectives* To determine the tolerability, defined as…
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: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 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…
This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.
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…
Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.Secondary• To evaluate the overall safety profile of EDR to select an RP3D for the combination to be used in Part…
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 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…