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

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Other: Observation

• Registration Number: NCT05001087
• Lead Sponsor: Fondazione EMN Italy Onlus

Brief 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.

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 Timeline

• Study First Submitted: 2021-01-22
• Study Start: 2021-03-16
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1900

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients registry	Observation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (27)

A.O.U di Careggi; 🇮🇹 Firenze, Italy

Ospedale San Gerardo di Monza; 🇮🇹 Monza, Italy

Policlinico San Matteo Fondazione IRCCS; 🇮🇹 Pavia, Italy

Ospedale "Infermi"; 🇮🇹 Rimini, Italy

Policlinico Universitario Campus Biomedico; 🇮🇹 Roma, Italy

A.O Ordine Mauriziano; 🇮🇹 Torino, Italy

Ospedale di Circolo; 🇮🇹 Varese, Italy

AOU Ospedali Riuniti Umberto I; 🇮🇹 Ancona, Italy

Policlinico di Bari - Ematologia con Trapianto; 🇮🇹 Bari, Italy

Policlinico di Bari; 🇮🇹 Bari, Italy

Policlinico S. Orsola; 🇮🇹 Bologna, Italy

A.O. Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

AOU Policlinico Vittorio Emanuele; 🇮🇹 Catania, Italy

A.O.U Policlinico S. Martino; 🇮🇹 Genova, Italy

ASST Santi Paolo e Carlo; 🇮🇹 Milano, Italy

Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Istituto Nazionale Tumori; 🇮🇹 Milano, Italy

Ospedale Niguarda Cà Grande; 🇮🇹 Milano, Italy

A.O.U Federico II; 🇮🇹 Napoli, Italy

Ospedale Maggiore; 🇮🇹 Novara, Italy

A.O.U di Parma; 🇮🇹 Parma, Italy

Ospedale S. Eugenio; 🇮🇹 Roma, Italy

Policlinico Umberto I - Università La Sapienza; 🇮🇹 Roma, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

A.O. Santa Maria; 🇮🇹 Terni, Italy

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy

Policlinico Universitario di Udine; 🇮🇹 Udine, Italy