This phase 2 clinical trial will test the effectiveness of isatuximab(SAR650984) in patients with high-risk smoldering multiple myeloma. The primary outcome will be measured by the overall response. This trial is being conducted at Mount Sinai Hospital and Memorial Sloan Kettering Cancer Center in New York, New York, as well as University of Texas MD Anderson Cancer in Houston, Texas.
The details
Isatuximab is an immunotherapy that uses the body’s own immune system to identify and kill cancerous plasma B-cells. It is an antibody (protein in the immune system) that binds to CD38, a protein found on plasma cells. Antibody binding alerts other parts of the immune system to attack the cancer.
This trial will examine whether isatuximab is effective in smoldering multiple myeloma. The study will examine the overall response for 6 months and time to disease progression for 2 years.
Who are they looking for?
This trial is recruiting 61 patients with high-risk smoldering multiple myeloma who have not yet received treatment. Patients should not have significant cardiovascular disease or other illness. Ideal candidates should not have undergone surgery within 1 month prior to enrollment. Participants should have adequate organ function. Females should not be pregnant or breastfeeding. Males and females must agree to use contraception.
How will it work
Patients will be given isatuximab intravenously (through IV into a vein) on days 1, 8, 15, and 22 of cycle 1, days 1 and 15 of cycles 2-6, and on day 1 of cycles 7-30. Each cycle is 28 days long. Diphenhydramine (Benadryl) and methylprednisolone (Medrol) will be delivered intravenously and ranitidine (Zantac) by mouth 30 minutes before isatuximab infusion. This is to decrease the risk of side effects.
