In a nutshell
This paper compared the safety and effectiveness of daratumumab (Darzalex) in combination with bortezomib (Velcade) and dexamethasone (Ozurdex) in patients with relapsed or refractory multiple myeloma.
Multiple myeloma is a cancer of the plasma cells of the blood. Multiple myeloma can be refractory (not responding to treatment) or relapse (have a return of disease). In the Japanese population, the incidence of multiple myeloma has increased over the past 25 years. Daratumumab is a drug that activates cancer cell death. Daratumumab has been shown to be effective on its own and in combination with bortezomib, another drug used in multiple myeloma. However, a combination of daratumumab and other drugs has not yet been studied in Japanese patients.
Methods & findings
Eight Japanese patients with relapsed or refractory multiple myeloma were enrolled in the study. Patients received daratumumab, bortezomib and dexamethasone. One patient stopped treatment due to prostate cancer. Patients received an average 8 treatment cycles over an average 5.3 months. They were followed-up for an average 5.5 months.
All patients experienced at least one treatment related adverse event (undesired outcome of treatment). The most common adverse events were blood-related, including low levels of platelets (cells involved in clotting) and low levels of lymphocytes (white blood cells). Two patients had treatment related infections. Infusion-related reactions (when drug is given into the vein), such as wheezing and chills were experienced by 5 patients. The dosage of daratumumab was modified in 4 patients due to adverse events.
All patients responded to treatment. The average time to a first response to treatment was 0.9 months. The average duration of response was 4.1 months.
The bottom line
The authors concluded that a combination of daratumumab with bortezomib is expected to be safe and effective in Japanese patients with relapsed or refractory multiple myeloma.
The fine print
There was a small number of patients studied. Larger studies are needed.
Published By :
International journal of hematology
Dec 19, 2017
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