"Although there is a general tendency to achieve a deep therapy response before
ASCT, further analyses should be performed to answer this question."
The approval is based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent in newly diagnosed
ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone.
The Ministry's approval is based on data from the phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50% in newly diagnosed
ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone.
placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone
ASCT; this study is currently enrolling
All patients were treated with
ASCT and BV prior to nivolumab.
Among patients who achieved CR or PR, 3 eventually received
ASCT.
In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for
ASCT.
However, a more common approach seems to be initial salvage HDCT with
ASCT.
It is significantly better, however, in those patients who had craniocaudal irradiation or
ASCT. Although this data is biased as these are selected patients who responded to their initial treatment [3, 5], in more recent publications, nevertheless, there is a promising increase in survival [7].
We included all clinical studies that had patients with relapsed Ewing's sarcoma who were treated with HDCT followed by
ASCT using either bone marrow or peripheral blood stem cell rescue regardless of treatment settings.
Autologous HSCT (
ASCT) is a pivotal therapeutic option for patients with multiple myeloma (MM) who are eligible for transplantation and achieve at least partial response after combination chemotherapy [1].
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