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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione EMN Italy Onlus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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