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

May 7, 2026 updated by: Carolina Terragna, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Bo
      • Bologna, Bo, Italy, 40138
        • Recruiting
        • IRCCS AOU Policlinico Sant'Orsola
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

September 29, 2032

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMAPPIN'
  • RC-2025-2797263 (Other Grant/Funding Number: Ministero della Salute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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