In a nutshell
The aim of this study was to evaluate the long-term safety and effectiveness of adding daratumumab (Darzalex) to RVd (lenalidomide/bortezomib/dexamethasone) therapy, followed by D-R (daratumumab/lenalidomide) maintenance for patients with newly diagnosed multiple myeloma (MM). The study found that this treatment was well tolerated and effective in the long term.
MM is a type of blood cancer that impacts bone marrow. There are many therapies for MM, including combination therapies and autologous stem cell transplant (ASCT). For an ASCT, healthy blood cells are taken from the patient and transplanted to replace the bone marrow that was destroyed. Some patients need additional care or therapy after treatment to ensure that the cancer does not come back (maintenance therapy).
There are different combinations of drugs that can be used to treat patients with MM. RVd is one regimen often used for patients who are eligible for ASCT. Daratumumab is an immunotherapy that can be combined with RVd (D-RVd) to increase the chances of effectively killing all the cancer cells. This combination has proven safe and effective for the treatment of MM in the short-term. However, it is not yet clear if D-RVd, followed by D-R maintenance therapy is safe and effective for treating patients with newly diagnosed MM in the long term.
Methods & findings
This study included data from 16 patients with newly diagnosed MM that were eligible for ASCT. All patients were treated with D-RVd, followed by ASCT. Patients were then given D-R maintenance therapy for 2 years. The average follow-up time was 40.8 months.
3 patients reported side effects associated with the dose of D-RVd. These side effects included fatigue, high blood pressure, and inflammation of the lungs, stomach + intestine. 15 patients completed the therapy regimen. Less serious side effects were reported by 15 patients. The most reported side effects were reduced blood clotting, low white blood cell levels, inflammation of the lungs, and high blood pressure.
At the end of maintenance therapy, 93.8% of patients had achieved a complete response (complete disappearance of cancer signs). 81.3% of patients did not have any MM cells left in the body. 50% of patients still did not have any MM cells left after at least 12 months.
After three years, 78.1% of patients had survived without progression of the disease.
The bottom line
The study concluded that D-RVd and D-R maintenance is safe and effective for treating patients with newly diagnosed MM.
The fine print
The sample size was very small. This trial received support from Janssen, the manufacturer of daratumumab.
Published By :
Feb 23, 2021
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