Table 10: Ongoing safety concerns. Additional Assigned safety Actions/outcome Estimated planned activity concern proposed submission of final data RRMM PASS Safety profile in a To monitor safety in a Annual safety updates “real (ongoing) world’ setting, world” situation. submitted with the ‘real foetal exposure PSUR (teratogenicity, Important identified risk) MDS PASSes Safety profile in a To gather safety data on the Annual safety updates (presumed world’ setting, use of lenalidomide in MDS submitted with the ‘real ongoing) off-label use patients and monitor PSUR [European (Important potential use (prospective risk) disease registry in transfusion-dependent and INT-1-risk MDS with an isolated del 5q and a retrospective drug utilisation study of Revlimid in MDS). Pooled Thromboembolic To determine the incident of To be submitted in the analysis of events (Important VTEs and ATEs in patients next PSUR update. data from identified risk) with MM, with clinical trials consideration of the of Revlimid thromboprophylactic agents used. NDMM AML and B-cell The primary objectives of Annual safety updates CONNECT malignancies the registry will be to submitted with the Registry (identified/potential describe practice patterns of PSUR (ongoing) risk) common first-line and [United States] subsequent treatment Non-melanoma skin regimens (including cancer lenalidomide-based) as well (identified/potential as diagnostic patterns and risk) SPM occurrence in the Other Second community and academic Primary Malignancy settings. (Important potential Additionally, the registry risk) will provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression free survival) in patients with symptomatic NDMM. CONNECT Other second The primary objectives of Annual safety updates MDS/AML primary malignancy the registry will be to submitted with the Registry describe practice patterns of PSUR. (presumed common first-line treatment
Table 10: Ongoing safety concerns. Additional activity Assigned safety concern Actions/outcome proposed Estimated planned submission of final data RRMM PASS (ongoing) Safety profile in a ‘real world’ setting, foetal exposure (teratogenicity, Important identified risk) To monitor safety in a “real world” situation. Annual safety updates submitted with the PSUR MDS PASSes (presumed ongoing) [European Safety profile in a ‘real world’ setting, off-label use (Important potential risk) To gather safety data on the use of lenalidomide in MDS patients and monitor use (prospective disease registry in transfusion-dependent and INT-1-risk MDS with an isolated del 5q and a retrospective drug utilisation study of Revlimid in MDS). Annual safety updates submitted with the PSUR Pooled analysis of data from clinical trials of Revlimid Thromboembolic events (Important identified risk) To determine the incident of VTEs and ATEs in patients with MM, with consideration of the thromboprophylactic agents used. To be submitted in the next PSUR update. NDMM CONNECT Registry (ongoing) [United States] AML and B-cell malignancies (identified/potential risk) Non-melanoma skin cancer (identified/potential risk) Other Second Primary Malignancy (Important potential risk) The primary objectives of the registry will be to describe practice patterns of common first-line and subsequent treatment regimens (including lenalidomide-based) as well as diagnostic patterns and SPM occurrence in the community and academic settings. Additionally, the registry will provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression free survival) in patients with symptomatic NDMM. Annual safety updates submitted with the PSUR CONNECT MDS/AML Registry (presumed Other second primary malignancy The primary objectives of the registry will be to describe practice patterns of common first-line treatment Annual safety updates submitted with the PSUR.
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