A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione EMN Italy Onlus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None considered
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Observation
Other interventionNot applicable-Observational study
Treatment groups
1,900 Participants
are divided into 1 treatment groupGroup A: Patients registry1 intervention
Trial outcomes
Primary outcomes
1
Overall survival (OS)
Time between diagnosis and death.
Time frame
3 years2
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.
Time frame
3 yearsSecondary outcomes
1
Patient reported outcomes (PROs)
Periodic completion of the EORTC-QLQ-C30 to evaluate the quality of life of the patients.
Time frame
3 years2
Costs incurred by the patients
Evaluation of the costs incurred by the patients related to the therapy based on the different treatments.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione EMN Italy Onlus
Lead sponsor
Amgen
Collaborator
GlaxoSmithKline
Collaborator
Janssen-Cilag S.p.A.
Collaborator
Sanofi
Collaborator
Takeda
Collaborator
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov