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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 .
Bortezomib/dexamethasone is a combination drug against multiple myeloma. [1] When bortezomib is used by the trade name Velcade, the combination is called Vel/Dex (or Vel-Dex or Veldex ). Bortezomib is a proteasome inhibitor and dexamethasone is a corticosteroid .
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]
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