Background Lenalidomide and dexamethasone has been a standard of care in transplant-ineligible patients with newly diagnosed multiple myeloma. The addition of a third drug to the combination is likely to improve treatment efficacy. KEYNOTE-185 assessed the efficacy and safety of lenalidomide and dexamethasone with and without pembrolizumab in patients with previously untreated multiple myeloma. Here, we present the results of an unplanned interim analysis done to assess the benefit-risk of the combination at the request of the US Food and Drug Administration (FDA).Methods KEYNOTE-185 was a randomised, open-label, phase 3 trial done at 95 medical centres across 15 countries (
The c-rel protooncogene encodes a subunit of the NF-KB-like family of transcription factors. Mice lacking Rel are defective in mitogenic activation of B and T lymphocytes and display impaired humoral immunity. In an attempt to identify changes in gene expression that accompany the T-cell stimulation defects associated with the loss of Rel, we have examined the expression of cell surface activation markers and cytokine production in mitogen-stimulated Rel-/-T cells. The expression of cell surface markers including the interleukin 2 receptor a (IL-2Ra) chain (CD25), CD69 and L-selectin (CD62) is normal in mitogen-activated Rel-/-T cells, but cytokine production is impaired. In Rel-/-splenic T cell cultures stimulated with phorbol 12-myristate 13-acetate and ionomycin, the levels of IL-3, IL-5, granulocytemacrophage colony-stimulating factor (GM-CSF), tumor necrosis factor a (TNF-a), and y interferon (IFN-y) (12,(17)(18)(19). Rel/ NF-KB has also been implicated in transcriptional regulation of other cytokine genes expressed in activated T cells (5, 18). The promoters of the genes encoding IL-3, IL-5, tumor necrosis factor a (TNF-a), granulocyte-macrophage colonystimulating factor (GM-CSF) and y interferon (IFN-3y)
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