A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])
A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])
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.
Inclusion Criteria:
Exclusion Criteria:
Kortijk, 8500, Belgium
Sint Niklass, 9100, Belgium
Deggendorf, 94469, Germany
Country Offaly, R35 NY51, Ireland
Allessandria, 15121, Italy
Avianno, 33081, Italy
Bologna, 40138, Italy
Nuoro, 8100, Italy
Regio Calabria, 89125, Italy
Lørenskog, 1478, Norway
Liverpool, L9 7AL, United Kingdom
Norfolk, NR4 7UY, United Kingdom