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

NCT07582354 | Recruiting

• 2 other identifiers: MMAPPIN'RC-2025-2797263
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU Policlinico Sant'Orsola

Bologna, Bo, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and bone marrow blood

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Carolina Terragna, MD

CONTACT

0512143831; carolina.terragna@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: May 12, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): September 29, 2032
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

IT (1)