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To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs PFS in subjects receiving Rd alone.
To determine if maintenance treatment with lenalidomide prolongs progression free survival in patients with advanced stage CTCL that has notbeen previously treated with intravenous chemotherapy except the chemotherapy received in the preceeding…
Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn*s Disease.
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of Lenalidomide added to standard induction chemotherapy for AML and select the feasible dose level for part B of the study2. To assess in a randomized…
To investigate the effects of the different combinations of propofol and remifentanil on the isobole of TOL90 and to compare hemodynamics, cerebral and tissue oxygenation for each equipotent combination. To describe the combination of propofol and…
Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…
Objectives:The following objectives are designed to address the effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease.Primary Objective: The…
1.1 Safety To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn*s disease 1.2 Efficacy * To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and the Crohn*s Disease Activity Index (CDAI)* To…
To investigate the feasibility and efficacy of a maximum of 6 cycles of Chlorambucil with Rituximab plus Lenalidomide at the RDL.
2.1 Primary objective * To determine the feasibility (as measured by non-relapse mortality after 7 months) of the regimen of Ibritumomab, followed by a reduced intensity, partial T cell-depleted allogeneic stem cell transplantation and…
1. To quantify the influence of propofol on the distribution, redistribution and elimination of ketamine and to evaluate the importance of hemodynamic parameters on the pharmacokinetics of ketamine.2. To quantify the influence of ketamine on the…
Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
The primary objective of this study is to confirm the efficacy and safety of Genz 112638 after 39 weeks of treatment in patients with Gaucher disease type 1.The secondary objective of this study is to determine the long term efficacy, safety, and…
To study the efficacy of low dose Lenalidomide maintenance combined with bortezomib treatment following non myeloablative Allo-SCT on Event Free Survival.
Phase I:-To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule.Phase II:-To…
Primary Objective: The primary objective is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. Secondary Objectives: Evaluate the efficacy…
The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…
Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…
The objective of this study is to evaluate the safety and efficacy of A-002 when added to atorvastatin plus standard-of-care in subjects with an ACS. Specifically this study will examine the effect of treatment on morbidity and mortality as defined…