About 500 patients will be enrolled in the trial, which will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
The company intends to start patient enrollment in the coming months and the primary endpoint of the trial is progression free survival (PFS).
Genmab chief executive officer Jan van de Winkel said, "The daratumumab development program is progressing very well. We are extremely pleased to be able to announce that this study evaluating daratumumab in combination with a core multiple myeloma treatment regime will initiate patient recruitment in the coming months."
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity and is currently in clinical development for treatment of multiple myeloma.
The drug targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells.
The US Food and Drug Administration (FDA) had already granted breakthrough therapy status for daratumumab.