Daratumumab (Darzalex®) Infosheet

This Horizons Infosheet contains information on daratumumab, a drug being investigated for the treatment of myeloma.

Daratumumab is a new drug being investigated for the treatment of myeloma. Daratumumab is a monoclonal antibody which attaches specifically to a protein that is present on the surface of myeloma cells.

Daratumumab has shown to be effective as a monotherapy. It is also being trialled in combination with other antimyeloma treatments such as dexamethasone, bortezomib (Velcade®) and lenalidomide (Revlimid®). Trials are being carried out in both newly diagnosed and relapsed and/or refractory patients.

The most commonly observed side-effect of daratumumab is an ‘infusion reaction’, which most often occurs within three to four hours of receiving the intravenous infusion. This can include fever, chills, cough, nausea, changes in blood pressure, flushing, rash and fatigue. An infusion reaction is typically more likely to occur with the first infusion rather than second or subsequent. Other side-effects reported include: low white blood cell levels (leukopenia); low platelet
levels (thrombocytopenia); low red blood cell levels (anaemia) and elevated liver enzymes.

One of the challenges of giving daratumumab is that the intravenous infusion takes a long time – in particular, the first dose can take several hours to administer. The phase I PAVO trial investigated a subcutaneous (under the skin) method of administering daratumumab, in a matter of minutes, with promising results: subcutaneous daratumumab was found
to be tolerable with fewer occurrences of infusion reactions when compared to giving it intravenously. Further research
into this method of administration is ongoing.

For an up-to-date list of UK clinical trials involving daratumumab, visit the Myeloma Trial Finder on