AIM AND SCOPE OF THE STUDY:
This project management plan is to conduct the clinical study to determine dose and regimen of Durvalumab as monotherapy or in combination with Pomalidomide with or without Dexamethasone in subjects with relapsed and refractory multiple myeloma.
The clinical study details are as follows:
Study Type: Interventional Study which is a multi centered and multi country clinical trial determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with pomalidomide (POM) with or without low dose dexamethasone in subjects with Relapsed and Refractory Multiple Myeloma (RRMM).
Study Design:
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel
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The sites are located at USA, France, Germany, Spain, The Netherlands, Canada and Italy etc and the locations are provided below:
University of Arkansas, Arkansas, USA
John Hopkins Oncology Center, Baltimore, Maryland, USA
Dana-Faber Partners Cancer Care, Inc., Boston, MA, USA
Hackensack University Medical Center, Hackensack, New Jersey, USA
Mt. Sinai School of Medicine, New York, USA
Weill Medical College of Cornell University, New York, USA
Levine Cancer Institute, Charlotte, NC, USA
Ohio State Medical Center, Columbus, Ohio, USA
Medical College of Wisconsin, Milwaukee, Wisconsin, USA
Tom Baker Cancer Center, Calgary, Alberta, Canada
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang, Lille, France
CHU La Miletrie, Poitiers Cedex, France
Hopital Purpan, Toulouse Cedex, France
Universitaetsklinikum Carl Gustav Carus, Dresden, Germany
Universitaetsklinikum EssenZentrum fuer Innere Medizin, Essen, Germany
University of Heidelberg, Heidelberg, Germany
Klinik f. Innere Medizin, Tumstr. 21, Germany
Universitatsklinikum Tubingen, Tubingen, Germany
Universitatsklinikum Würzburg, Würzburg, Germany
Nazionale Dei Tumori, Milano, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Italy
VU University Medical Center VU Medisch Centrum, Amsterdam, Netherlands
Erasmus Medical Center, Rotterdam,
Since four to five regional offices should be set, the other locations should be Middle Atlantic and West South Central. The specific numbers are as following:
Multiple Myeloma is a form of cancer which affects the plasma cells of the body, which are white blood cells. Multiple Myeloma, first described in 1848, is a disease “characterized by a proliferation of malignant plasma cells and a subsequent overabundance of monoclonal paraprotein.” To understand how Multiple Myeloma affects an infected person’s plasma cells, it helps to have a general understanding of how normal blood cells are formed and how they act. Most blood cells develop from stem cells, which can be found in bone marrow (soft material inside our bones – the “filling”). Stem cells mature into white blood cells, red blood cells, or platelets.2 The purpose of white blood cells is to fight off infection, while
U.S., Singapore, UK, Spain, and Germany; with Belgium, Ireland, Israel, UAE/Dubai, France making up ten countries in total.
• Are the servers of VPN network under consideration located in other countries as well?
It will consist of 10 arms or sub-studies. The study requires the participants to be at least 18 years or older to enroll. The participants must have advance solid tumors and lymphomas that are no longer responding to standard therapy and have begun to grow. The participants will undergo DNA sequencing to identify genetic abnormalities that may respond to the targeted drugs selected for the trail. These drugs that will be given to the participants will have either been approved by the U.S. Food and Drug Administration or are still being tested in other clinical trials but have shown effectiveness against tumors with genetic alterations. 20 to 25 drugs will be tested in different arms of the
The immaturity of the data is underscored by the disposition at the time of analysis. Patients were more likely to have discontinued based on adverse events than to have had disease progress or be continuing therapy. Although tolerability looked better when only patients receiving tremelimumab 1 mg were analyzed, even in that group, 30% of patients had a related grade > 3 adverse event, with 16% of patients discontinuing due to an adverse event and 4% dying from the study therapy. For comparison, in the studies that led to approval of pembrolizumab and nivolumab, grade > 3 related adverse events were seen in 7-10.5%, adverse events led to discontinuation of study therapy in 0.2-3.8% and death was related to study treatment in 0-0.3%.2, 3, 4
The trial involves giving a combination therapy to patients with advanced squamous cell carcinoma. Patients with advance malignancies may have other comorbidities and may be receiving multiple medications. This will increase the risk of side effects and the possibility of drugs interactions when receiving the investigational product. The investigational product itself has a wide range
This newsletter is designed to help practising pharmacists understand the application of the basis sciences to practice concerning adalimumab. Lots of practical advice is based on pharmaceutical sciences but once you enter practice it can be hard to remember or find out the basis of why we advise patients in specific ways or why you or other health professionals should handle medicines in certain ways.
Both of the presented patients had positive response to therapy after Rituximab injection as their MMSE increased remarkably. Also Rituximab has decreased FBDS episodes. Moreover, It should be noted that psychotic symptoms in the second patient were also resolved following Rituximab injection. Both patients satisfactorily tolerated Rituximab and had no side effects after injection. In summery this two case reports were successful examples of the treatment of LE with Rituximab.
What if patients that suffer from Multiple Myeloma could finally have a treatment opinion with the aid of the immunology hormone, Thymosin ß-4? This hematologic (blood) disease has no cure at this specific time, but there are some factors that increase the susceptibility of contracting this disease. The factors include being over the age of 65, hereditary disposition and race also, people that already suffer a blood disease will probably contract MM. Why is trying to treat MM so important? Multiple Myeloma is stated as a cancer that is formed in a specific type of white blood cell (plasma cells). The main role of plasma cells is to secrete antibody that recognizes and attacks germs. These malignant plasma cells result in an increase of immunoglobulin components, most commonly IgG. This up regulation of IgG can ultimately cause kidney problems. To fully understand how this hormone may help patients that suffer from this disease first, I want to look at how the immune system interacts with hormones. Then, discuss what Thymosin ß-4 is and the effects on the inhibition of MM.
Patients are selected randomized to receive Rituximab 400 mg intravenous (IV) every 3 weeks up to1 year. Patients are randomized to the standard of care for chemotherapy will get treatment as per the Physician’s choice and suggested dosage. All patients will be called for the follow up for up to 2 years after last dose of drug or until the death. The overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and clinical advantage will be observed.
Patients with standard-risk myeloma have a median overall survival (OS) of 6–7 years while those with high-risk disease have a median OS of less than 2–3 years despite tandem autologous stem cell
When Lilly Research Laboratories were developing and screening naphtaheleneyloxy – arylprpylamines series, in August 2003, for serotonin and norepinephrine reuptake inhibitor, they found that Duloxetine, a member of this series, proved efficiency in treatment of major depression disorder , owing to Duloxetine is a balanced 5-hydroxytryptamine and norepinephrine dual reuptake inhibitor with minor inhibitory effect on dopamine. [1]
Rituximab, better known by its trade name Rituxan®, is a monoclonal antibody medication administered intravenously. Genentech, Inc and IDEC Pharmaceuticals manufacture Rituximab. 1,3 It is a drug used to treat several diseases including: Rheumatoid Arthritis (RA), along with other prescribed medicines; Non-Hodgkin’s Lymphoma (NHL), either alone or with other chemotherapy medicines; Chronic Lymphocytic Leukemia (CLL), along with other chemotherapy medicines fludarabine and cyclophosphamide; Granulomatosis with Polyangiitis (GPA); and Microscopic Polyangiitis (MPA), along with glucocorticoids. 1,2 Cost of treatment varies on the disease. Rituximab costs are about $ per mg/l .
De-livering an outcome hard to digest: The acceptable toxicity level of new chemotherapeutic regimen in treating metastatic colorectal cancer may improve liver resections.