80 results
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…
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…
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 of the study is to evaluate if rovalpituzumab tesirine improves progression-free and overall survival in subjects with extensive-stage SCLC who have ongoing clinical benefit (SD, PR, or CR) following the completion of 4 cycles…
This study aims to re-examine the bioequivalence of prednisolone and dexamethasone at two different doses by assessing tissue specific glucocorticoids effects, including the immune system, brain functioning, hormonal axes, and renal parameters.
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.
The study will look at patients with relapsed (returned after prior treatment) and refractory (not responsive to prior treatment) multiple myeloma. The research aims to compare a new drug called elotuzamab combined with standard of care (…
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:…
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 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 purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in subjects with relapsed or refractory MM.1. Primary objectiveThe primary objective of this study is to compare PFS between…
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 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…
The objective of this study is to evaluate the effectiveness of different treatments to prevent CME after cataract surgery, using either topical drugs (control group) or intra-/periocular injections (intervention groups).
Primary Objective• Evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to standard immunochemotherapy Secondary Objectives• Further evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to…
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 ObjectiveThe primary objective of the study is to determine the recommended dose and regimen ofdurvalumab either as monotherapy or in combination with POM +/- dex in subjects with RRMM.Secondary ObjectivesThe secondary objectives are to:*…
The primary objective of the study is :To assess MRD negativity rate by NGF after 9 cycles for all eligible ITT patients of KRd versus Rd in patients with high-risk SMMSecondary objectives:• To assess MRD (NGF) negativity rate after 4 cycles of…