Multiple Myeloma
Conditions
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.
Interventions
OTHERObservation
Not applicable-Observational study
Sponsors
Fondazione EMN Italy Onlus
Amgen
GlaxoSmithKline
Janssen-Cilag S.p.A.
Sanofi
Takeda
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | Time between diagnosis and death. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes (PROs) | 3 years | Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients. |
| Costs incurred by the patients | 3 years | Evaluation of the costs incurred by the patients related to the therapy based on the different treatments. |
Countries
Italy
Contacts
CONTACTMario Boccadoro
Outcome results
None listed