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 (CC-5013-MCL-005)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective non-interventional study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX04) lenalidomide

  lenalidomide
• Medical condition to be studied:
  Mantle cell lymphoma

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  560

Study design details

• Main study objective:
  To quantify and characterize tumor flare reaction (TFR) by tumor burden (assessed based on last CT scan performed within up to 2 months prior to initiation of lenalidomide administration) in Relapsed Refractory Mantle Cell Lymphoma (R/R MCL) patients treated with lenalidomide in a real-world setting
• Outcomes:
  To quantify and characterize the event of tumor flare reaction (TFR) in R/R MCL patients treated with lenalidomide. To quantify and characterize the proportion of early deaths (defined as deaths within 20 weeks of the initial administration of lenalidomide) by tumor burden in R/R MCL patients treated with lenalidomide.
• Data analysis plan:
  The analysis will be descriptive and no a priori hypotheses will be tested. All analyses will be stratified according to baseline tumor burden. The proportion of patients with high tumor burden at baseline will be estimated with its two-sided 95% CI. The cumulative incidence of TFR and early death will be calculated. The frequency of TFR and other adverse events related to lenalidomide collected and not listed in the current SmPC will also be reported in summary tables. Any TFR events will be descriptively reported for up to 6 months of treatment. Time to event analyses and incidence rates for TFR and early death will be estimated using the Kaplan-Meier method. Since data is being collected retrospectively, the number of time points each patient may have will be unknown a priori. KM analyses will not be performed as primary but as complementary analyses. Exploration of factors associated with TFR and with early death will be conducted in multivariate analyses.