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NCT05001087 Clinical Trial

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

Multiple Myeloma Clinical Trial

— MY MYELOMA  

Official title:
A "Physician & Patient-powered" Cohort Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05001087
Other study ID # 535/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 16, 2021
Est. completion date March 1, 2024

Study information
Verified date September 2023
Source Fondazione EMN Italy Onlus
Contact Mario Boccadoro
Phone +390110243236
Email clinicaltrialoffice@emnitaly.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1900
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Not applicable-Observational study

Locations
Country Name City State
Italy AOU Ospedali Riuniti Umberto I Ancona
Italy Policlinico di Bari Bari
Italy Policlinico di Bari - Ematologia con Trapianto 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 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) Meldola
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

Sponsors (1)
Lead Sponsor Collaborator
Fondazione EMN Italy Onlus

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) Time between diagnosis and death. 3 years
Primary 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. 3 years
Secondary Patient reported outcomes (PROs) Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients. 3 years
Secondary Costs incurred by the patients Evaluation of the costs incurred by the patients related to the therapy based on the different treatments. 3 years
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