In a nutshell
This study investigated the effects of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan (Alkeran), and prednisone (Deltasone) among patients with newly diagnosed multiple myeloma who are not candidates for transplant. The main finding was that this regimen safely improved survival in such patients.
Some background
Multiple myeloma is a cancer that affects the immune system. It can be treated with stem-cell transplantation. Patients who are ineligible for transplant are conventionally treated with different combinations of lenalidomide (Revlimid), dexamethasone (Ozurdex), bortezomib, melphalan, and prednisone.
Recently, combining the immunotherapy drug daratumumab (D) with bortezomib, melphalan, and prednisone (VMP) prevented cancer progression in such patients. However, the effects of D-VMP in long-term survival is unknown.
Methods & findings
706 patients with newly diagnosed multiple myeloma were included in this study. They were ineligible for transplant because of advanced age and other medical conditions. 350 of them received D-VMP. 356 patients received VMP. All patients were followed up for 40.1 months on average.
D-VMP treatment reduced the risk of death by 40% compared to VMP alone. The overall survival (OS) was calculated for 36-months after the start of therapy. The rate of OS was 78% in the D-VMP group. This was compared to 67.9% in the VMP group.
On average, patients had survived without cancer growing or spreading for 36.4 months in the D-VMP group. This was compared to 19.3 months in the VMP group. The D-VMP group was 58% more likely to have a longer survival without cancer growing or spreading.
Overall 90.9% of patients receiving D-VMP responded to treatment. This was compared to 73.9% in the VMP group. No new concern regarding the safety of D-VMP was found.
The bottom line
The authors concluded that treatment with D-VMP safely improved survival in patients with newly diagnosed multiple myeloma who were not eligible for transplant.
The fine print
Patients in the VMP group stopped treatment after 9 cycles, whereas the D-VMP group continued to receive daratumumab. This might have affected the results. This study was sponsored by Janssen Research & Development, the manufacturer of daratumumab.
Published By :
Lancet (London, England)
Date :
Dec 10, 2019