In a nutshell
This study evaluated the clinical effectiveness and safety of daratumumab (Darzalex) treatment for patients with heavily pre-treated multiple myeloma (MM) in a real-world setting. The study showed that daratumumab is safe and effective in these patients.
MM is a type of cancer that affects white blood cells called plasma cells. Considerable progress has been made in the treatment of the MM with next-generation proteasome inhibitors (PI) such as and immunomodulatory derivatives (IMDs). PIs block molecules called proteasomes that normally chew up excess proteins. If these proteasomes are blocked, excess proteins build up in myeloma cells and kill them. IMDs regulate the immune system to kill cancer cells.
However, relapses are quite common. Daratumumab is an FDA-approved targeted immunotherapy. It targets an immune protein on MM cells and enables the immune system to target and kill MM cells. Previous clinical trials have shown that daratumumab alone improves the outcomes of patients with previously treated MM. However, patients are carefully selected for a clinical trial. Older patients and those with other medical conditions are commonly excluded. Therefore, the safety and effectiveness of daratumumab in previously treated patients with MM in a real-world setting are still unknown.
Methods & findings
This study included 62 patients with relapsed/refractory multiple myeloma (RRMM). Patients had been previously treated with PIs and IMiDs for an average of 3 therapies. Patients were treated with 16 mg/kg daratumumab weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks. The average follow-up was 23.7 months.
46% of patients responded to daratumumab treatment. 28% had stable disease (MM did not shrink or worsen). The average period MM did not worsen was 2.7 months. The average overall survival was 22.4 months.
The most common severe side effects were low blood cell counts, respiratory infections, and tiredness.
The bottom line
The study showed that daratumumab was generally well-tolerated with and effective in heavily pre-treated patients with multiple myeloma in a real-world setting.
The fine print
This was a small study. Larger studies are needed.
Published By :
Annals of Hematology
Feb 02, 2021
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