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It was approved for use in the United States in May 2020. [2] [7] [8]Efficacy of daratumumab and hyaluronidase-fihji (monotherapy) was evaluated in the COLUMBA trial (NCT03277105), an open-label non-inferiority trial randomizing 263 participants to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV). [2]
Daratumumab was given priority review status by the US Food and Drug Administration (FDA) for multiple myeloma as a combination therapy (second line). [24] Daratumumab phase III trials for multiple myeloma show great promise in combination therapy with lenalidomide and dexamethasone, [32] as well as with bortezomib and dexamethasone. [33 ...
Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. [6] Often, no symptoms are noticed initially. [10] As it progresses, bone pain, anemia, renal insufficiency, and infections may occur. [10]
Survival rate is a part of survival analysis.It is the proportion of people in a study or treatment group still alive at a given period of time after diagnosis. It is a method of describing prognosis in certain disease conditions, and can be used for the assessment of standards of therapy.
In survival analysis, the hazard ratio (HR) is the ratio of the hazard rates corresponding to the conditions characterised by two distinct levels of a treatment variable of interest. For example, in a clinical study of a drug, the treated population may die at twice the rate of the control population.
Survival rates for most childhood cancers have improved, with a notable improvement in acute lymphoblastic leukemia (the most common childhood cancer). Due to improved treatment, the 5-year survival rate for acute lymphoblastic leukemia has increased from less than 10% in the 1960s to about 90% during the time period 2003-2009.
Milatuzumab (or hLL1) is an anti-CD74 [1] humanized monoclonal antibody for the treatment of multiple myeloma non-Hodgkin's lymphoma and chronic lymphocytic leukemia. [2] [3]The drug is the first anti-CD74 antibody that has entered into human testing and is currently being studied for the treatment of multiple myeloma.
NRI attempts to quantify how well a new model correctly reclassifies subjects. Typically this comparison is between an original model (e.g. hip fractures as a function age and sex) and a new model which is the original model plus one additional component (e.g. hip fractures as a function of age, sex, and a genetic or proteomic biomarker).