54 results
Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…
The primary objective is to assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB (Carbon-11 labeled Pittsburgh Compound B) PET Amyloid Scanning in patients with Mild Cogntitive…
The objectives of this study are to:• Evaluate the safety, tolerability, and immunogenicity of long-term treatment with intravenous (IV) ATYR1940 in adult patients with facioscapulohumeral muscular dystrophy (FSHD) previously enrolled in clinical…
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…
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
Primary objectives:*To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 when administered as a 21-day or 28 day CIV infusion to patients with refractory hematologic malignancies.*To assess the safety and…
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…
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…
The primary objective is to determine the safety and the maximum tolerated dose of dasatinib in combination with lenalidomide and low dose dexamethasone in subjects with relapsed or refractory multiple myeloma
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
To study the efficacy of low dose Lenalidomide maintenance combined with bortezomib treatment following non myeloablative Allo-SCT on Event Free Survival.
To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs PFS in subjects receiving Rd alone.
1. To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months.2. To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo.
Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…
To investigate the feasibility and efficacy of a maximum of 6 cycles of Chlorambucil with Rituximab plus Lenalidomide at the RDL.
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 and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
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…
Primary Objective1. To evaluate the safety and tolerability of long-term dosing of losmapimod tablets in subjects with FSHD1Secondary Objectives1. To assess target engagement of losmapimod tablets in blood and skeletal muscle over long term dosing2…
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.