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NCT05712967
Role of the Host Microbiota and Il-17 in Favoring Multiple Myeloma Progression
Conditions: Multiple Myeloma
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 62
Sponsor: IRCCS San Raffaele
Location: Italy
Summary
Goal of this observational, non-interventional study is to demonstrate that in humans a correlation exists between bone marrow (BM) levels of the cytokine interleukin 17 (IL-17) and composition of the gut microbiota in patients affected by smoldering multiple myeloma (SMM) or multiple myeloma (MM).Enrolled SMM/MM patients will be analyzed for their bone marrow levels of IL-17 together with the distribution of T helper 17 lymphocytes in their BM and peripheral blood.
These analyses will be correlated with analyses of the patients' gut microbiome to identify commensal bacteria potentially involved in Th17 cell expansion.
Eligibility Criteria
Inclusion Criteria:patients fulfilling the International Myeloma Working Group (IMWG) diagnostic criteria for SMM or MM, and 10 healthy controls older than 18 years and accepting to sign the informed consentExclusion Criteria:Non-Caucasian subjects.Subjects younger than 18 years.Subjects that did not accept to sign the informed consent.Subjects reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy or prophylaxis.Subjects who already underwent HSCT or under pharmacologic therapy for MM.Subjects affected by autoimmune diseases with the exception of thyroiditis.Subjects affected by HIV, HBV or HCV.
Source: ClinicalTrials.gov (NCT05712967). StuddyBuddy aggregates publicly available trial information.