In a nutshell
This article investigated the safety and effectiveness of adding daratumumab (Darzalex) to bortezomib (Velcade) and dexamethasone (Decadron) for the treatment of relapsed or refractory (does not respond to treatment) multiple myeloma (RRMM). The authors concluded that the addition of daratumumab is safe and gave the greatest benefit to patients that were treated at their first relapse.
Some background
Multiple myeloma (MM) is a cancer of plasma cells. These are a type of white blood cell normally responsible for producing antibodies. Bortezomib and dexamethasone are a standard treatment for these patients. However, as MM progresses, there is a reduction in the response to treatments due to decreased sensitivity.
An alternative treatment method is immunotherapy. This treatment uses monoclonal antibodies (laboratory-produced molecules engineered to stimulate the immune system to destroy cancer cells). Daratumumab is a type of immunotherapy. Added to bortezomib and dexamethasone, daratumumab has been shown to induce rapid and long-standing responses in relapsed patients. However, the effect on overall survival and safety of daratumumab are still under investigation.
Methods & findings
This study involved 498 patients with RRMM who had been previously treated. They were randomly assigned to two groups. Group 1 received treatment with daratumumab added to bortezomib and dexamethasone (251 patients). Group 2 received treatment with bortezomib and dexamethasone alone (247 patients). The outcomes measured were; progression-free survival (PFS; the time it took for cancer to start growing again), time to disease progression, overall response rate (ORR), minimal residual disease (MDR; a small number of cancer cells that remain in the blood while the patient is in remission) and side effects.
After an average of 19.4 months, group 1 had significantly longer PFS (16.7 months) compared to group 2 (7.1 months). The group that received daratumumab were 69% less likely to have cancer progression compared with the group that did not. Group 1 had an ORR of 83.8% compared with 63.2% in group 2. 11.6% of group 1 patients were MRD negative compared with 2.4 % of group 2.
The most common side effects reported included low platelet count (cells involved in blood clotting), anemia, pneumonia, high blood pressure, and peripheral nerve disease. These did not affect the quality of life of patients treated with daratumumab.
The bottom line
The authors concluded that the addition of daratumumab to bortezomib and dexamethasone is safe and effective in patients with RRMM.
The fine print
The study was sponsored by Janssen Research & Development, LLC. the manufacturer of daratumumab.
Published By :
Haematologica
Date :
Sep 20, 2018
