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Multiple MyelomaMY MYELOMANCT05001087

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

An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 27 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Observation
How many people
1,900 participants
Where
27 sitesItaly
Study dates
16 Mar 2021to 31 Mar 2027
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • None considered

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mario Boccadoro contact

+390110243236

clinicaltrialoffice@emnitaly.org

27 sites in 1 country

Italy27 sites, 26 recruiting

  • AOU Ospedali Riuniti Umberto I

    Ancona

    Massimo Offidani, MD

    Massimo Offidani, MD

    Recruiting

  • Policlinico di Bari - Ematologia con Trapianto

    Bari

    Pellegrino Musto, Prof

    Pellegrino Musto, Prof.

    Not yet recruiting

  • Policlinico di Bari

    Bari

    Roberto Ria, MD

    Roberto Ria, MD

    Recruiting

  • Policlinico S. Orsola

    Bologna

    Elena Zamagni, Prof.

    Elena Zamagni, Prof.

    Recruiting

  • A.O. Spedali Civili di Brescia

    Brescia

    Angelo Belotti, MD

    Angelo Belotti, MD

    Recruiting

  • AOU Policlinico Vittorio Emanuele

    Catania

    Concetta Conticello

    Concetta Conticello, MD

    Recruiting

  • A.O.U di Careggi

    Florence, Firenze, 50134

    Elisabetta Antonioli

    Elisabetta Antonioli, MD

    Recruiting

  • A.O.U Policlinico S. Martino

    Genova

    Sara Aquino, MD

    Sara Aquino, MD

    Recruiting

  • ASST Santi Paolo e Carlo

    Milan

    Vittorio Montefusco, MD

    Vittorio Montefusco, MD

    Recruiting

  • Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico

    Milan

    Loredana Pettine, MD

    Loredana Pettine, MD

    Recruiting

  • Istituto Nazionale Tumori

    Milan

    Paolo Corradini

    Paolo Corradini, Prof.

    Recruiting

  • Ospedale Niguarda Cà Grande

    Milan

    Anna Maria Cafro, MD

    Anna Maria Cafro

    Recruiting

  • Ospedale San Gerardo di Monza

    Monza

    Sara Pezzatti, MD

    Sara Pezzatti, MD

    Recruiting

  • A.O.U Federico II

    Naples

    Fabrizio Pane, Prof.

    Fabrizio Pane, Prof.

    Not yet recruiting

  • Ospedale Maggiore

    Novara

    Gloria Margiotta Casaluci

    Gloria Margiotta Casaluci, MD

    Recruiting

  • A.O.U di Parma

    Parma

    Nicola Giuliani, Prof.

    Nicola Giuliani, Prof.

    Recruiting

  • Policlinico San Matteo Fondazione IRCCS

    Pavia

    Silvia Mangiacavalli, MD

    Silvia Mangiacavalli, MD

    Recruiting

  • Ospedale "Infermi"

    Rimini

    Terminated

  • Ospedale S. Eugenio

    Roma

    Luca Cupelli, MD

    Luca Cupelli, MD

    Recruiting

  • Policlinico Umberto I - Università La Sapienza

    Roma

    Maurizio Martelli, Prof.

    Maurizio Martelli, Prof.

    Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma

    Ombretta Annibali, MD

    Ombretta Annibali, MD

    Recruiting

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

    Antonietta Falcone, MD

    Antonietta Falcone, MD

    Recruiting

  • A.O. Santa Maria

    Terni

    Arcangelo Liso, Prof.

    Arcangelo Liso, Prof.

    Recruiting

  • A.O Ordine Mauriziano

    Torino

    Guido Parvis, MD

    Guido Parvis, MD

    Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino

    Alessandra Larocca, MD

    Alessandra Larocca, MD

    Recruiting

  • Policlinico Universitario di Udine

    Udine

    Francesca Patriarca, Prof.

    Francesca Patriarca, Prof.

    Recruiting

  • Ospedale di Circolo

    Varese

    Marta Coscia, Prof.

    Marta Coscia, Prof.

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Observation
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    Not applicable-Observational study

Study groups in NCT05001087
Study groupRoleWhat they receive
Patients registryNon-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.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Time between diagnosis and death.

    Measured: 3 years

  2. Time to next treatment (TTNT)

    Time to next treatment will be measured from the screening to the date of next anti-myeloma therapy, for each treatment regime.

    Measured: 3 years

Secondary outcomes (2)

  1. Patient reported outcomes (PROs)

    Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients.

    Measured: 3 years

  2. Costs incurred by the patients

    Evaluation of the costs incurred by the patients related to the therapy based on the different treatments.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start16 Mar 2021
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,900 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05001087
Sponsor's protocol ID
535/2020
Acronym
MY MYELOMA
Status last verified
Sep 2026
First submitted
22 Jan 2021
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 27 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mario Boccadoro (+390110243236, clinicaltrialoffice@emnitaly.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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