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

Celgene

Status: Completed

Conditions: Lymphoma, Mantle-Cell

Treatments: Drug: Lenalidomide

Study type: Observational

Funder types: Industry

Identifiers

NCT03647124

U1111-1213-1816 (Registry Identifier)

CC-5013-MCL-005

EUPAS23366 (Registry Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

105 participants in 1 patient group

Lenalidomide treated Relapsed or refractory mantle cell lymphoma (R/R-MCL) participants in Europe

Treatment:

Drug: Lenalidomide