Detailed Description:
This is a European multinational, retrospective, non-interventional study of participants
with relapsed or refractory mantle cell lymphoma (R/R MCL). Potential sites will be
identified where R/R MCL participants have been treated with lenalidomide. Site inclusion
will be limited to countries where lenalidomide is reimbursed for this indication.
Inclusion Criteria:
Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment
of relapsed refractory mantle cell lymphoma.
Informed consent of the patient or an authorized third person or authority, if required by
law, given prior to data collection.
Patient must be ≥18 years of age at the time of signing the informed consent form.
Exclusion Criteria:
1) Patients will be excluded if they were participating in an interventional clinical trial
during the treatment period under observation in this Post Authorization Safety Study.
Primary outcome:
1. To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting. (Time Frame - Approximately 8.5 years):
To quantify and characterize the event of TFR by tumor burden (assessed based on the last CT scan performed within a maximum of 2 months prior to initiation of administration of lenalidomide) in R/R MCL patients treated with lenalidomide in a real-world setting.
Secondary outcome:
1. To quantify and characterize the proportion of early deaths by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting (Time Frame - Approximately 8.5 years):
To quantify and characterize the proportion of early deaths (defined as deaths within 20 weeks of initial administration of lenalidomide) by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.
- Lenalidomide (Revlimid / L04AX04 / ):
Specified dose on specified days
Quelle: ClinicalTrials.gov
