A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Celgene105 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

105

Conditions

Lymphoma, Mantle-Cell

Interventions

LenalidomideDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (79)

Outcomes

Primary Outcomes

To quantify and characterize the event of TFR by tumor burden in R/R MCL patients treated with lenalidomide in a real-world setting.

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.

Time frame: Approximately 8.5 years

Secondary Outcomes

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

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.

Time frame: Approximately 8.5 years

Data from ClinicalTrials.gov

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Local Institution - 105

Graz, Austria

LKH Graz Medizinische Universitätsklinik

Graz, Austria

LKH Hochsteiermark, Standort Leoben

Leoben, Austria

Local Institution - 104

Leoben, Austria

Local Institution - 102

Salzburg, Austria

Salzburger Landeskliniken - Universitaetsklinikum Salzburg

Salzburger, Austria

AKH Wien, Universitaetsklinik fuer Innere Medizin III

Vienna, Austria

Local Institution - 101

Vienna, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

Local Institution - 103

Wiener Neustadt, Austria

...and 69 more locations