Evaluating the effectiveness and safety of isatuximab in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma.

This study evaluated the long-term effectiveness and safety of isatuximab (Sarclisa) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone (Decadron) (Pd) in previously treated patients with relapsed or refractory (r/r) multiple myeloma (MM). The data showed that isatuximab plus Pd combination significantly improved the overall survival compared to Pd alone in these patients.  

Multiple myeloma (MM) is a type of cancer that comes from blood cells called plasma cells. A high number of patients with MM experience relapse (the tumor grows after treatment) or are refractory (not responsive to the treatment) to standard treatment. Currently, the treatment strategies for r/r MM are based on the different combinations of conventional and novel drugs.

One standard treatment combination for r/r MM is pomalidomide (Pomalyst) combined with dexamethasone (Pd). Isatuximab is an immunotherapy drug that has been approved for the treatment of r/r MM. It has been shown to improve the outcomes of these patients when combined with Pd therapy. However, the long-term effectiveness and safety of isatuximab in combination with the Pd regimen in previously treated patients with r/r MM is still not known.

This study involved 307 patients with r/r MM. Patients were randomly assigned into 2 groups. Group 1 included 154 patients who received isatuximab + Pd combination. Group 2 included 153 patients who received Pd alone. The average follow-up time was 35.3 months.

The average overall survival was 24.6 months in group 1 versus 17.7 months in group 2. Patients in group 1 were 24% more likely to have a better survival compared to patients in group 2.

The average survival without cancer worsening was 11.1 months in group 1 versus 5.9 months in group 2. Patients in group 1 were 40% more likely to survive without cancer worsening compared to patients in group 2.

73% of the patients in group 1 experienced serious treatment-related side effects compared to 60% of the patients in group 2. The most common side effects were low white blood cell counts (50% in group 1 vs 35% in group 2), pneumonia (23% in group 1 vs 21% in group 2), and low platelet counts (13% in group 1 vs 12% in group 2).

This study concluded that the isatuximab plus Pd combination significantly improved the overall survival compared to Pd alone in previously treated patients with r/r MM.  

This study was sponsored by Sanofi, the manufacturers of isatuximab. The patients knew which treatment they were getting. This might have influenced the results.