NCT06767254

Brief Summary

This is a non-interventional, national, multicenter prospective non-profit observational study aiming at improving the accuracy of risk prediction in multiple myeloma (MM) by applying machine-learning tools for data processing to develop model(s) predicting response to therapy and the probability of early relapse for MM patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Oct 2024

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Oct 2024Aug 2026

Study Start

First participant enrolled

October 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

January 9, 2025

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

January 2, 2025

Last Update Submit

January 8, 2025

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Overall Response Rate

    12 months after the start of anti-MM therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be adult patients with newly diagnosed (ND) multiple myeloma.

You may qualify if:

  • Age ≥ 18 years
  • Signed Informed Consent form for study participation and personal data processing
  • Diagnosis of active multiple myeloma

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

Meldola, Forlì-Cesena, 47014, Italy

NOT YET RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

ARNAS "G. Brotzu" di Cagliari

Cagliari, 09134, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Elena Zamagni, MD, PhD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Zamagni, MD, PhD

CONTACT

+39 051 214 3680e.zamagni@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 9, 2025

Study Start

October 30, 2024

Primary Completion

April 2, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

January 9, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)