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
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.
Full Title of Study: “A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: December 31, 2026
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
- Drug: Lenalidomide
- Specified dose on specified days
Arms, Groups and Cohorts
- Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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.
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Celgene
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
- Overall Contact(s)
- BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com
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