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

NCT ID: NCT05001087

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Observation

Intervention Type OTHER

Not applicable-Observational study

Interventions

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Observation

Not applicable-Observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Janssen-Cilag S.p.A.

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Takeda

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Fondazione EMN Italy Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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A.O.U di Careggi

Florence, Firenze, Italy

Site Status RECRUITING

AOU Ospedali Riuniti Umberto I

Ancona, , Italy

Site Status RECRUITING

Policlinico di Bari - Ematologia con Trapianto

Bari, , Italy

Site Status NOT_YET_RECRUITING

Policlinico di Bari

Bari, , Italy

Site Status RECRUITING

Policlinico S. Orsola

Bologna, , Italy

Site Status RECRUITING

A.O. Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

AOU Policlinico Vittorio Emanuele

Catania, , Italy

Site Status RECRUITING

A.O.U Policlinico S. Martino

Genova, , Italy

Site Status RECRUITING

ASST Santi Paolo e Carlo

Milan, , Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori

Milan, , Italy

Site Status RECRUITING

Ospedale Niguarda Cà Grande

Milan, , Italy

Site Status RECRUITING

Ospedale San Gerardo di Monza

Monza, , Italy

Site Status RECRUITING

A.O.U Federico II

Napoli, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Maggiore

Novara, , Italy

Site Status RECRUITING

A.O.U di Parma

Parma, , Italy

Site Status RECRUITING

Policlinico San Matteo Fondazione IRCCS

Pavia, , Italy

Site Status RECRUITING

Ospedale "Infermi"

Rimini, , Italy

Site Status TERMINATED

Ospedale S. Eugenio

Roma, , Italy

Site Status RECRUITING

Policlinico Umberto I - Università La Sapienza

Roma, , Italy

Site Status RECRUITING

Policlinico Universitario Campus Biomedico

Roma, , Italy

Site Status RECRUITING

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status RECRUITING

A.O. Santa Maria

Terni, , Italy

Site Status RECRUITING

A.O Ordine Mauriziano

Torino, , Italy

Site Status RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status RECRUITING

Policlinico Universitario di Udine

Udine, , Italy

Site Status RECRUITING

Ospedale di Circolo

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mario Boccadoro

Role: CONTACT

[email protected]
+390110243236

Facility Contacts

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Elisabetta Antonioli

Role: primary

Massimo Offidani, MD

Role: primary

Pellegrino Musto, Prof

Role: primary

Roberto Ria, MD

Role: primary

Elena Zamagni, Prof.

Role: primary

Angelo Belotti, MD

Role: primary

Concetta Conticello

Role: primary

Sara Aquino, MD

Role: primary

Vittorio Montefusco, MD

Role: primary

Loredana Pettine, MD

Role: primary

Paolo Corradini

Role: primary

Anna Maria Cafro, MD

Role: primary

Sara Pezzatti, MD

Role: primary

Fabrizio Pane, Prof.

Role: primary

Gloria Margiotta Casaluci

Role: primary

Nicola Giuliani, Prof.

Role: primary

Silvia Mangiacavalli, MD

Role: primary

Luca Cupelli, MD

Role: primary

Maurizio Martelli, Prof.

Role: primary

Ombretta Annibali, MD

Role: primary

Antonietta Falcone, MD

Role: primary

Arcangelo Liso, Prof.

Role: primary

Guido Parvis, MD

Role: primary

Alessandra Larocca, MD

Role: primary

Francesca Patriarca, Prof.

Role: primary

Marta Coscia, Prof.

Role: primary

Other Identifiers

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535/2020

Identifier Type: -

Identifier Source: org_study_id

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