An observational study in Multiple Myeloma, sponsored by Fondazione EMN Italy Onlus. Recruiting at 27 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Fondazione EMN Italy Onlus · Observational
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.
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 1,900 is above the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Fondazione EMN Italy Onlus is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Overall survival (OS)
Time between diagnosis and death.
Time frame: 3 years
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.
Time frame: 3 years
Patient reported outcomes (PROs)
Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients.
Time frame: 3 years
Costs incurred by the patients
Evaluation of the costs incurred by the patients related to the therapy based on the different treatments.
Time frame: 3 years
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Fondazione EMN Italy Onlus