11 results
For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic…
Primary Objective:To compare the progression-free survival (PFS) of transplant-ineligible subjects with newly diagnosed multiple myeloma who are treated withcarfilzomib, melphalan, and prednisone (CMP) versus those treated with bortezomib (Velcade…
The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…
The purpose of this study is to demonstrate that in patients with DVT or PE who use a strong CYP 3A4 inducer, the use of this higher rivaroxaban dose results in a similar rivaroxaban concentration in the blood and a rivaroxaban induced blood…
The aim of this study is to improve the outcome of both younger and elderly primary plasma cell leukemia patients(pPCL) by using next generation novel agents and in case of younger patients also the tandem of auto-SCT and allo-SCT.
Primary Objective: • To compare efficacy of once-weekly KRd (56 mg/m2 ) to twice-weekly KRd (27 mg/m2) in subjects with RRMM with 1 to 3 prior lines of therapyKey Secondary Objectives: • To compare progression-free survival (PFS) between treatment…
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…
Primary objectives- Evaluate the efficacy, defined as PFS, of pomalidomide maintenance plus dexamethasone versus pomalidomide maintenance in patients who responded (>= PR) to the combination of pomalidomide (POM), carfilzomib (CAR) and low…
The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination…
Primary objective-To compare rate of Minimal Residual Disease (MRD) negativity by NGS between Isa-KRd and KRd in post ASCT consolidation treatment.Key secondary objectives- Rate of MRD negativity after induction by NGS- To compare progression-free…
The Primary Objectives of the Phase 1b are: • To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory ALL • To determine the maximum…