Adding daratumumab to lenalidomide and dexamethasone therapy for the treatment of patients with newly diagnosed multiple myeloma.

This study evaluated the effectiveness and safety of adding daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone (Decadron) therapy for patients with newly diagnosed multiple myeloma (MM). The data showed that adding daratumumab to the lenalidomide and dexamethasone (Rd) regimen was safe and improved the survival of these patients.

Multiple myeloma (MM) is a type of cancer that comes from blood cells called plasma cells. The standard therapy for patients who are newly diagnosed with MM is chemotherapy and a stem cell transplant. Some patients are not eligible for a transplant due to advanced age or additional medical conditions and receive other therapy. Currently, the treatment strategies for newly diagnosed MM are based on the different combinations of conventional drugs and novel drugs.

One standard treatment combination for newly diagnosed MM is lenalidomide in combination with dexamethasone (Rd). Lenalidomide is an immunotherapy drug that boosts the body’s immune system to help it attack cancer cells. Daratumumab is an immunotherapy drug that directly targets the cancer cells to kill them. Daratumumab combined with the Rd regimen (D-Rd) has been previously shown to improve the survival outcomes in patients with previously treated unresponsive MM. However, the effectiveness and safety of adding daratumumab to Rd therapy for patients with newly diagnosed MM who cannot undergo transplantation are still unknown.

The study involved 737 patients with newly diagnosed MM. Patients were randomly assigned into 2 groups. Group 1 included 368 patients who received daratumumab + Rd treatment. Group 2 included 369 patients who received Rd alone treatment. The average follow-up time was 56.2 months.

The average survival without cancer worsening was not reached (exceeded the average follow-up period) in group 1 compared to 34.4 months in group 2. Patients in group 1 were 47% less likely to have cancer worsening than patients in group 2. After 60 months, 52.5% of the patients in group 1 were alive without disease progression compared to 28.7% of the patients in group 2.

The average overall survival was not reached (exceeded the average follow-up period) in both groups. Daratumumab + Rd treatment reduced the risk of death by 32% compared to Rd treatment alone. After 60 months, 66.3% of the patients in group 1 were alive compared to 53.1% of the patients in group 2.

77% of the patients in group 1 experienced severe side effects compared to 70% of patients in group 2. The most common side effects were low white blood cell counts (54% in group 1 vs 37% in group 2), pneumonia (19% in group 1 vs 11% in group 2), low lymphocyte counts (16% in group 1 vs 11% in group 2), and anemia (17% in group 1 vs 22% in group 2). 

This study concluded that adding daratumumab to lenalidomide and dexamethasone regimen increased the survival of patients with newly diagnosed MM ineligible for transplantation.

This study was sponsored by Janssen, the manufacturers of daratumumab. The patients knew which treatment they had been given. This may have influenced the results.