About this trial
This is a single-center, observational study in patients with multiple myeloma, conducted both retrospectively and prospectively. The study aims to improve understanding of the biological and clinical factors that influence disease progression, relapse, and treatment resistance.
The study will integrate clinical information with advanced genomic and molecular analyses, including whole genome and RNA sequencing, as well as circulating tumor markers, to identify features linked to therapy response and disease behavior. All data will be securely stored, maintaining patient confidentiality, to build a comprehensive map of multiple myeloma that may guide more personalized future treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+
Signed CI for study partecipation and personal data processing.
Diagnosis of monoclonal gammopathy, or of acrive multiple myaloma (NDMM/RMM/RRMM)
Disqualifiers
None
Trial population
Study participants will be adult patients with monoclonal gammopathies, NDMM, RMM, and RRMM. Basing on data of yearly access, the study aims to enroll approximately: * 400 NDMM patients in a -36 months timeframe * 20 patients with monoclonal gammopathies in a -36 months timeframe * 50 RMM patients in a -36 months timeframe * 50 RRMM patients in a -36 months timeframe In addition, a retrospective cohort of patients will be included in this study after obtaining signed informed consent. This cohort will comprise no more than 25% of the total enrolled participants regardless of the phase of their disease. Patients will be selected based on the availability of existing residual biological material (samples collected not before January 2020), which will be analyzed as part of this study.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Response assessment (according to IMWG criteria) and / or disease progression (PD)
Secondary outcomes
Response to treatment <VGPR (according to IMWG criteria) and/or disease progression (PD)
Presence and/or absence of "secondary" tumor clone(s)
Presence and/or absence of differences between baseline characteristics and progression features
Sponsors and contacts
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