Daratumumab plus bortezomib, melphalan, and prednisone for newly diagnosed myeloma

This paper studied the effect of daratumumab together with bortezomib, melphalan, and prednisone in patients with newly diagnosed multiple myeloma. The study found that the addition of daratumumab improved survival. 

Multiple myeloma is a cancer of the plasma cells of the blood. Daratumumab (Darzalex) is a drug that targets cancer cells. In patients who have previously received treatment, daratumumab together with standard regimens such as bortezomib (Velcade) or lenalidomide (Revlimid) improves survival. It is not clear whether it is effective as a first-line treatment. 

This paper compared the outcome of bortezomib, melphalan (Alkeran), and prednisolone with or without daratumumab. 706 patients with newly diagnosed multiple myeloma who were not eligible for stem cell transplant were studied. 350 patients received daratumumab, bortezomib, melphalan and prednisolone. 356 patients received bortezomib, melphalan and prednisolone without daratumumab.

Disease progression (worsening disease) or death had occurred in 25.1% of patients who received daratumumab. Disease progression or death occurred in 40.2% of patients who did not receive daratumumab. Patients who received daratumumab were 50% less at risk of disease progression or death compared to patients who did not receive daratumumab.

At 12 months, 86.7% of patients who received daratumumab had survived. At 12 months, 76.0% of patients who did not receive daratumumab had survived.  42.6% of patients who received daratumumab had a complete response (no sign of active disease) to treatment. 24.4% of patients who did not receive daratumumab had a complete response to treatment.

With regards to safety, low neutrophil (type of white blood cell) levels were the most common side effect of treatment. 49.7% of patients who received daratumumab had low levels of neutrophils. 52.5% of patients who did not receive daratumumab had low levels of neutrophils. Serious infections occurred in 23.1% of patients who received daratumumab and 14.7% of patients who did not. Death due to infection occurred in 1.4% of patients who received daratumumab and 1.1% of patients who did not.  

The authors concluded that in patients with newly diagnosed multiple myeloma, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same treatment without daratumumab.