This phase 1 clinical trial will test the safety of isatuximab (SAR650984) in patients with relapsed or refractory multiple myeloma, as well as the effectiveness of isatuximab in multiple myeloma patients who have been previously treated with daratumumab (Darzalex). The primary outcome will be measured by side effects and overall response.
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 cells.
The study will divided into parts A and B. Part A will examine the dose limiting side effects (side effects that prevent dose increases) for 4 weeks and the number of patients with adverse (negative) side effects for up to 12 months. Part B will measure the response rate in patients previously treated with daratumumab for 4 months.
Who are they looking for?
This trial is recruiting 64 patients with relapsed or refractory multiple myeloma. Patients enrolling in part A should have received at least three prior treatments or be double refractory to an immunomodulatory drug and proteasome treatment. Patients should have received at least one alkylating agent (such as melphalan) and achieved minimal response to some type of treatment.
Patients enrolling in part B should have received at least two cycles of daratumumab and achieved minimal response to at least one line of treatment.
Participants should have adequate organ function and bone marrow reserve.
How will it work
Patients will be given increasing intravenous (delivered through IV into a vein) doses of isatuximab throughout a 28-day cycle. The drug will be delivered on days 1, 8, 15, and 22 of cycle 1 then on days 1 and 15 of the following cycles. Patients in part A will be evaluated for dose limiting side effects. Patients in part B will be evaluated for the overall response to treatment. Treatment will occur until the disease progresses.
