This phase II trial evaluates whether giving isatuximab before and after autologous stem cell transplant (ASCT) can alter the immune system and make the transplant more effective for patients with multiple myeloma or lymphoma. Isatuximab is a monoclonal antibody that binds to a protein called CD38, which can be found on some types of immune cells and certain types of cancer cells. This may help the immune system kill cancer cells. ASCT is a procedure in which stem cells are collected from a patient and then returned to them after receiving chemotherapy to kill cancer cells. This clinical trial tests whether giving isatuximab before and after ASCT alters the patient's immune system so they recover more quickly and fight the cancer better.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05346809.
PRIMARY OBJECTIVE:
I. Evaluate the effect of isatuximab administration prior to stem cell collection and transplantation on immune repertoire of the stem cell product and immune recovery.
SECONDARY OBJECTIVE:
I. Establish safety of isatuximab use in the peri-transplant period.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive isatuximab intravenously (IV) over 30-60 minutes on days 1 and 8. Patients receive filgrastim (SC) on days 9-13 and then undergo stem cell collection. Patients undergo ASCT and conditioning. Patients receive isatuximab IV over 30-60 minutes again on days 15, 22, and 30 post ASCT.
ARM II: Patients receive filgrastim, undergo stem cell collection, and undergo ASCT and conditioning as in Arm I.
After completion of study treatment, patients are followed up at 60, 90, and 180 days, at 1 year, then every 6 months for up to 2 years.
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorDivaya Bhutani