This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.
Study Type
OBSERVATIONAL
Enrollment
911
Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
Innsbruck University Hospital
Innsbruck, Austria
LKH Hochsteiermark
Leoben, Austria
University hospital St. Pölten
Pölten, Austria
CHU Saint-Pierre
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
CHU-Charleroi
Incidence of cardiovascular events
Number of participants with cardiovascular adverse events
Time frame: Approximately 8 years
Incidence of renal impairment in NDMM patients
To document renal function among TNE NDMM patients treated with a first-line regimen
Time frame: Approximately 8 years
Incidence of infections in NDMM patients
To document the severity of infections among TNE NDMM patients treated with a first-line regimen.
Time frame: Approximately 8 years
Incidence of Second primary malignancy (SPM) in TNE NDMM patients treated with any first line regimen
Secondary primary malignancies will be categorized according to whether they are invasive and non-invasive malignancies.
Time frame: Approximately 8 years
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Brussels, Belgium
CHU-Charleroi
Charleroi, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge
Kortijk, Belgium
CHR Citadelle Liège
Liège, Belgium
...and 115 more locations