A "physician & Patient-powered" Cohort Registry (MY MYELOMA) (MY MYELOMA)

February 25, 2025 updated by: Fondazione EMN Italy Onlus

A "physician & Patient-powered" Cohort Registry

The aim of this observational study is the creation of a national multiple myeloma registry to monitor the current routine clinical practice in Italy and describe the standard of care adopted for the diagnosis and treatment of patients with multiple myeloma in the different Italian hematology centers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In Italy, myeloma accounts for 1.3% of all tumour diagnoses in males and for 1.2% of all tumour diagnoses in women. The incidence is 9.5 new cases per 100,000 males and 8.1 cases per 100,000 females. Median age at diagnosis is 68 years and approximately 2% of patients experience onset before the age of 4011. Therefore is to establish a national disease registry to monitor current routine clinical practice in Italy and to describe the standard of care adopted for the diagnosis and treatment of patients with myeloma. National registries have already been established in some countries and a recently-published meta-analysis highlighted certain differences in treatment, survival and the demographic characteristics of patients. An Italian national registry is important for analysing the current situation, in order to deal with the changes that lie ahead. In addition to the standard epidemiological registry - as described in the statistical methods section - a patientpowered registry (PPR) will also be established to encourage patient participation.

Study Type

Observational

Enrollment (Estimated)

1900

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
      • Ancona, Italy
        • Recruiting
        • Aou Ospedali Riuniti Umberto I
        • Contact:
          • Massimo Offidani, MD
      • Bari, Italy
        • Recruiting
        • Policlinico di Bari
        • Contact:
          • Roberto Ria, MD
      • Bari, Italy
        • Not yet recruiting
        • Policlinico di Bari - Ematologia con Trapianto
        • Contact:
          • Pellegrino Musto, Prof
        • Contact:
          • Pellegrino Musto, Prof.
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola
        • Contact:
          • Elena Zamagni, Prof.
      • Brescia, Italy
        • Recruiting
        • A.O. Spedali Civili di Brescia
        • Contact:
          • Angelo Belotti, MD
      • Catania, Italy
        • Recruiting
        • AOU Policlinico Vittorio Emanuele
        • Contact:
          • Concetta Conticello
        • Contact:
          • Concetta Conticello, MD
      • Firenze, Italy, 50134
        • Recruiting
        • A.O.U di Careggi
        • Contact:
          • Elisabetta Antonioli
        • Contact:
          • Elisabetta Antonioli, MD
      • Genova, Italy
        • Recruiting
        • A.O.U Policlinico S. Martino
        • Contact:
          • Sara Aquino, MD
      • Milano, Italy
        • Recruiting
        • Istituto Nazionale Tumori
        • Contact:
          • Paolo Corradini
        • Contact:
          • Paolo Corradini, Prof.
      • Milano, Italy
        • Recruiting
        • Asst Santi Paolo E Carlo
        • Contact:
          • Vittorio Montefusco, MD
      • Milano, Italy
        • Recruiting
        • Ospedale Niguarda Cà Grande
        • Contact:
          • Anna Maria Cafro
        • Contact:
          • Anna Maria Cafro, MD
      • Milano, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
        • Contact:
          • Loredana Pettine, MD
      • Monza, Italy
        • Recruiting
        • Ospedale San Gerardo di Monza
        • Contact:
          • Sara Pezzatti, MD
      • Napoli, Italy
        • Not yet recruiting
        • A.O.U Federico II
        • Contact:
          • Fabrizio Pane, Prof.
      • Novara, Italy
        • Recruiting
        • Ospedale Maggiore
        • Contact:
          • Gloria Margiotta Casaluci
        • Contact:
          • Gloria Margiotta Casaluci, MD
      • Parma, Italy
        • Recruiting
        • A.O.U di Parma
        • Contact:
          • Nicola Giuliani, Prof.
      • Pavia, Italy
        • Recruiting
        • Policlinico San Matteo Fondazione IRCCS
        • Contact:
          • Silvia Mangiacavalli, MD
      • Rimini, Italy
        • Terminated
        • Ospedale "Infermi"
      • Roma, Italy
        • Recruiting
        • Policlinico Umberto I - Università La Sapienza
        • Contact:
          • Maurizio Martelli, Prof.
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Biomedico
        • Contact:
          • Ombretta Annibali, MD
      • Roma, Italy
        • Recruiting
        • Ospedale S. Eugenio
        • Contact:
          • Luca Cupelli, MD
      • San Giovanni Rotondo, Italy
        • Recruiting
        • IRCCS Ospedale Casa Sollievo della Sofferenza
        • Contact:
          • Antonietta Falcone, MD
      • Terni, Italy
        • Recruiting
        • A.O. Santa Maria
        • Contact:
          • Arcangelo Liso, Prof.
      • Torino, Italy
        • Recruiting
        • AOU Città della Salute e della Scienza di Torino
        • Contact:
          • Alessandra Larocca, MD
      • Torino, Italy
        • Recruiting
        • A.O Ordine Mauriziano
        • Contact:
          • Guido Parvis, MD
      • Udine, Italy
        • Recruiting
        • Policlinico Universitario di Udine
        • Contact:
          • Francesca Patriarca, Prof.
      • Varese, Italy
        • Recruiting
        • Ospedale di Circolo
        • Contact:
          • Marta Coscia, Prof.

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The registry will include approximately 30 Italian haematology facilities. On the basis of the centres' enrolment capacity and incidence and epidemiology data it is reasonable to presume that at least 1900 patients will be enrolled in 3 years. Only patients who meet the eligibility criteria will be included in the registry.

Description

Inclusion Criteria:

  • Patients of both sexes
  • Age ≥ 18 years
  • Diagnosis of active/symptomatic multiple myeloma (according to CRAB and biological parameters) no earlier than 1st January 2019
  • Able and willing to sign an informed consent form

Exclusion Criteria:

  • None considered

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients registry

Non-interventional, multicentre, retrospective and prospective registry. In order to increase the sample size and the validity of the Registry, patients who were diagnosed with myeloma since 1st January 2019 will also be included retrospectively, once their informed consent has been obtained by the enrolling centre. Being a registry, patients will be enrolled consecutively according to their appointments at the centre, at the discretion of their doctor and only once the patient has signed the informed consent form.

Also patients participating in interventional or other observational studies can be enrolled. In case of patients enrolled in interventional trials, only baseline and survival data can be collected for the period in with the patient is in interventional trial.

The data will be collected using an electronic data capture (EDC) platform. Hospital visits are planned every 6 months.
Other: Observation
Not applicable-Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 3 years
Time between diagnosis and death.
3 years
Time to next treatment (TTNT)
Time Frame: 3 years
Time to next treatment will be measured from the screening to the date of next anti-myeloma therapy, for each treatment regime.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcomes (PROs)
Time Frame: 3 years
Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients.
3 years
Costs incurred by the patients
Time Frame: 3 years
Evaluation of the costs incurred by the patients related to the therapy based on the different treatments.
3 years

Collaborators and Investigators

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

Sponsor

Fondazione EMN Italy Onlus

Collaborators

Bristol-Myers Squibb
Sanofi
Takeda
Amgen
Janssen-Cilag S.p.A.
GlaxoSmithKline Research & Development Limited

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)

March 16, 2021

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 535/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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