Plain language summary on subcutaneous administration of isatuximab in people with relapsed and/or refractory multiple myeloma

Abstract

What is this summary about? This plain language summary describes the results of the first study on subcutaneous (under the skin) injection of a medicine called isatuximab for people with multiple myeloma. Multiple myeloma is a type of blood cancer. Isatuximab is approved in various countries, to be given as an intravenous infusion (into a vein) alongside other medicines for people with multiple myeloma. Subcutaneous injection would reduce the time needed for the injection to take place and decrease the need for nurses to be involved. Isatuximab was given to some people with multiple myeloma as a subcutaneous injection, using a new type of injector called an on-body delivery system (OBDS for short). Other people with multiple myeloma received isatuximab intravenously. This would allow for researchers to compare the results. Everyone in the study also received treatment with pomalidomide and low-dose dexamethasone. What were the results? The results of the study showed that isatuximab could be given as a subcutaneous injection using an OBDS. The side effects that people experienced were similar to those in people who received isatuximab as an infusion in the study described, as well as in the larger study called ICARIA-MM. People with multiple myeloma receiving subcutaneous isatuximab with an OBDS did not have any infusion/injection reaction. Side effects around the site of the injection were categorized as mild and infrequent. The OBDS injection took 10 minutes or less to complete for half of the people in the study. Multiple myeloma improved for 73% of people who received isatuximab as a subcutaneous OBDS injection. This was similar to people who received isatuximab as an intravenous infusion ? 67% of people?s multiple myeloma improved in this group. What do the results mean? In this study, subcutaneous injection of isatuximab using an OBDS worked as well as intravenous infusion, with similar side effects. Receiving isatuximab as a subcutaneous injection could be a more convenient treatment option for people with multiple myeloma.[Box: see text].