Adding daratumumab to pomalidomide and dexamethasone therapy for treatment of relapsed/refractory multiple myeloma.

This study evaluated the effectiveness and safety of adding daratumumab (Darzalex) to pomalidomide (Pomalyst) and dexamethasone (Decadron) therapy for patients with previously treated relapsed or refractory (r/r) multiple myeloma (MM). The data showed that adding daratumumab to pomalidomide and dexamethasone regimen reduced the risk of disease progression or death for these patients.

Multiple myeloma (MM) is a type of cancer that comes from blood cells called plasma cells. A high number of patients with MM experience relapse (the tumor grows after treatment) or are refractory (not responsive to the treatment) to standard treatment. Currently, the treatment strategies for r/r MM are based on the different combinations of conventional drugs and novel drugs.

One standard treatment combination for r/r MM is pomalidomide in combination with dexamethasone (Pd). Daratumumab is an immunotherapy drug that has been approved for the treatment of r/r MM. However, the effectiveness and safety of adding daratumumab to Pd therapy for patients with previously treated r/r MM are still unknown.

The study involved 304 patients with previously treated r/r MM. Patients were randomly assigned into 2 groups. Group 1 included 151 patients who received daratumumab + Pd treatment. Group 2 included 153 patients who received only Pd treatment. The average follow-up time was 16.9 months.

The average survival without progression or cancer worsening was 12.4 months in group 1 compared to 6.9 months in group 2. Patients in group 1 were 37% less likely to have progression or worsening of cancer than patients in group 2. After 18 months, 42% of the patients in group 1 were alive without disease progression compared to 26% of the patients in group 2.

50% of the patients in group 1 experienced severe side effects compared to 39% of patients in group 2. The most common side effects were pneumonia, respiratory infections, low platelet counts, low white blood cell counts, and anemia.  

This study concluded that adding daratumumab to pomalidomide and dexamethasone regimen reduced the risk of disease progression or death for the treatment of patients with previously treated r/r MM. 

The sample size of this study was small and the follow-up period was rather short. Further studies with longer follow-up are needed. This study was sponsored by Janssen, the manufacturers of daratumumab.