Multicenter Observational Study of Infectious Complications in Patients with Hematologic Malignancies Receiving Bispecific Antibody Therapy

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study aimed at understanding infectious complications in patients with blood cancers who are receiving bispecific antibody therapy. This study focuses on how often infections occur, their types and severity, and how these infections affect treatment outcomes. It also seeks to identify risk factors and compare infection rates across different blood cancers and types of bispecific antibodies. The study involves collecting data from multiple European centers treating hematologic patients. Participants include adults diagnosed with blood cancers like multiple myeloma or non-Hodgkin lymphoma who have started bispecific antibody treatment within the past 30 days. Data collected will include patient demographics, treatment details, infection types and severity, and outcomes related to infection such as hospitalizations and treatment delays. Information will be gathered at baseline and monthly for up to 12 months. Participants will provide informed consent and have their information recorded anonymously in a secure online database. The study will monitor infections confirmed by pathogens or probable infections based on symptoms and exams, excluding certain fever cases without localized infection. Researchers will assess infection incidence as the primary measure and analyze factors affecting infection risk and treatment outcomes. The study will last approximately 36 months from protocol approval, with data collection and analysis phases clearly outlined.

Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.