About this trial
This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL)
Receipt of CAR-T infusion at IRCCS AOUBo
Age ≥18 years at the time of CAR-T infusion
Signed informed consent
Disqualifiers
None
Trial population
Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
Secondary outcomes
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
Adjusted odds ratios with 95% confidence intervals for the association between predefined pre-infusion and post-infusion variables and the occurrence of at least one infectious complication after CAR-T infusion.
Classification of the first febrile episode within 30 days after CAR-T infusion.
Classification of each participant's first febrile episode as no fever, infection-related fever, indeterminate fever, or cytokine release syndrome (CRS)-related fever.
Participants with microbiologically documented infection at the first febrile episode.
Number (or percentage) of participants with a microbiologically documented infection identified at the time of the first febrile episode.
Post-Discharge Infectious Complications.
Percentage of participants with at least one infectious complication occurring after hospital discharge.
Sponsors and contacts
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