A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A "Physician & Patient-powered" Cohort Registry
Overview
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.
Interventions
- Other Observation
Not applicable-Observational study
Primary outcome measures
- Overall survival (OS) [Time frame: 3 years]
- Time to next treatment (TTNT) [Time frame: 3 years]
Secondary outcome measures (2)
- Patient reported outcomes (PROs) [Time frame: 3 years]
- Costs incurred by the patients [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 27 centers
- A.O.U di Careggi — Florence
- AOU Ospedali Riuniti Umberto I — Ancona
- Policlinico di Bari - Ematologia con Trapianto — Bari
- Policlinico di Bari — Bari
- Policlinico S. Orsola — Bologna
- A.O. Spedali Civili di Brescia — Brescia
- AOU Policlinico Vittorio Emanuele — Catania
- A.O.U Policlinico S. Martino — Genova
- … and 19 more centers
Identifiers
NCT: NCT05001087 · 535/2020