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Gabriela Chiorean.

Study End Points The principal efficacy end point was overall survival. The secondary end points were progression-free survival and the response rate as assessed through independent radiographic examine. Progression-free survival and response prices were also analyzed through investigator assessments. The %ages of sufferers with a maximum decrease in the CA19-9 degree of at least 20 percent and at least 90 percent had been also calculated for each treatment group. Treatment-related adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 . We calculated that with a sample of 842 sufferers with 608 events the analysis would have 90 percent power to detect a hazard ratio for death with nab-paclitaxel plus gemcitabine versus gemcitabine monotherapy of 0.769 at a two-sided alpha level of 0.049.Time-to-event end points were estimated from the time of enrollment and from enough time when the random assignment was disclosed . Progression-free of charge survival was calculated before time of disease progression, death from any trigger during treatment, or data censoring at the last day on which the patient was regarded as free of disease progression. General survival was calculated until the date of either loss of life from any cause or data censoring at the last time on which the individual was known to be alive. Response was assessed with the use of the International Uniform Response Criteria for Multiple Myeloma.23 Bone marrow samples were collected at enrollment and analyzed by central laboratories within each country.