Lymphoma, Mantle-Cell
Conditions
Keywords
Mantle Cell Lymphoma, MCL, Revlimid, Non-Interventional, PASS, CC-5013, Relapsed, Refractory, TFR, Tumor Flare Reaction, High Tumor Burden
Brief summary
The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.
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.
Interventions
DRUGLenalidomide
Specified dose on specified days
Sponsors
Celgene
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Austria, France, Germany, Greece, Italy, Netherlands, Spain
Outcome results
None listed