MMAPPIN' Study: Multiple Myeloma Analysis For Patient-specific Insights to Dissect Disease Heterogeneity

NCT07582354 — Recruiting, 520 participants, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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Registry	NCT07582354
Status	Recruiting
Study type	Observational
Enrollment	520 (Estimated)
Sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
Conditions	Myeloma Multiple
Dates	start 2025-10-15, primary completion 2026-10-15 (estimated), completion 2032-09-29 (estimated), first posted 2026-05-12, last updated 2026-05-12
Locations	1 site in Italy

-Summary

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.

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+Outcome measures

Primary outcomes

Response assessment (according to IMWG criteria) and / or disease progression (PD) [12 months after the start of therapy, in pre-neoplastic groups , only PD will be considered]

Secondary outcomes

Response to treatment <VGPR (according to IMWG criteria) and/or disease progression (PD) [From baseline to disease progression (PD), assessed up to 24 months.]
Presence and/or absence of "secondary" tumor clone(s) [From baseline to disease progression (PD), assessed up to 24 months.]
Presence and/or absence of differences between baseline characteristics and progression features [From baseline to disease progression (PD), assessed up to 24 months.]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age 18+
* Signed CI for study partecipation and personal data processing.
* Diagnosis of monoclonal gammopathy, or of acrive multiple myaloma (NDMM/RMM/RRMM)

Exclusion Criteria:

* None

+Locations (1)

Facility	City	Country	Status
IRCCS AOU Policlinico Sant'Orsola	Bologna, Bo	Italy	Recruiting