Clinical trial NCT05001087: A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)
Official title: A "Physician & Patient-powered" Cohort Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Fondazione EMN Italy Onlus
Sponsor class: OTHER
Collaborators: name: Amgen
name: GlaxoSmithKline Research & Development Limited
name: Janssen-Cilag S.p.A.
name: Sanofi
name: Takeda
name: Bristol-Myers Squibb
First posted: 2021-08-11
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Time to next treatment (TTNT)
timeFrame: 3 years
Secondary outcomes:
measure: Patient reported outcomes (PROs)
timeFrame: 3 years
measure: Costs incurred by the patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I
city: Bari
country: Italy
facility: Policlinico di Bari - Ematologia con Trapianto
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bologna
country: Italy
facility: Policlinico S. Orsola
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele
city: Firenze
country: Italy
facility: A.O.U di Careggi
city: Genova
country: Italy
facility: A.O.U Policlinico S. Martino
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Milano
country: Italy
facility: Ospedale Niguarda Cà Grande
city: Monza
country: Italy
facility: Ospedale San Gerardo di Monza
city: Napoli
country: Italy
facility: A.O.U Federico II
city: Novara
country: Italy
facility: Ospedale Maggiore
city: Parma
country: Italy
facility: A.O.U di Parma
city: Pavia
country: Italy
facility: Policlinico San Matteo Fondazione IRCCS
city: Rimini
country: Italy
facility: Ospedale "Infermi"
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Policlinico Umberto I - Università La Sapienza
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Terni
country: Italy
facility: A.O. Santa Maria
city: Torino
country: Italy
facility: A.O Ordine Mauriziano
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
city: Udine
country: Italy
facility: Policlinico Universitario di Udine
city: Varese
country: Italy
facility: Ospedale di Circolo
Study officials:
References: