A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)
MY MYELOMA
1 other identifier
observational
1,900
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedStudy Start
First participant enrolled
March 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 27, 2025
February 1, 2025
6 years
January 22, 2021
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Overall survival (OS)
Time between diagnosis and death.
3 years
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 Outcomes (2)
Patient reported outcomes (PROs)
3 years
Costs incurred by the patients
3 years
Study Arms (1)
Patients registry
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- None considered
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione EMN Italy Onluslead
- Amgencollaborator
- GlaxoSmithKlinecollaborator
- Janssen-Cilag S.p.A.collaborator
- Sanoficollaborator
- Takedacollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (27)
A.O.U di Careggi
Florence, Firenze, 50134, 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
Milan, Italy
Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
Milan, Italy
Istituto Nazionale Tumori
Milan, Italy
Ospedale Niguarda Cà Grande
Milan, Italy
Ospedale San Gerardo di Monza
Monza, Italy
A.O.U Federico II
Napoli, Italy
Ospedale Maggiore
Novara, Italy
A.O.U di Parma
Parma, Italy
Policlinico San Matteo Fondazione IRCCS
Pavia, Italy
Ospedale "Infermi"
Rimini, Italy
Ospedale S. Eugenio
Roma, Italy
Policlinico Umberto I - Università La Sapienza
Roma, Italy
Policlinico Universitario Campus Biomedico
Roma, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
A.O. Santa Maria
Terni, Italy
A.O Ordine Mauriziano
Torino, Italy
AOU Città della Salute e della Scienza di Torino
Torino, Italy
Policlinico Universitario di Udine
Udine, Italy
Ospedale di Circolo
Varese, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2021
First Posted
August 11, 2021
Study Start
March 16, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
February 27, 2025
Record last verified: 2025-02