A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory
Barbara Gamberi1, Christian Berthou2, Miguel Hernandez3
1Department of Hematology, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Clinical Lymphoma, Myeloma & Leukemia
|July 2, 2020
Summary
Lenalidomide plus dexamethasone is safe for relapsed/refractory multiple myeloma (RRMM) patients in real-world settings. This study found its safety profile comparable to clinical trials, with lower rates of neuropathy and infections than other treatments.
Area of Science:
- Hematology
- Oncology
- Clinical Pharmacology
Background:
- Relapsed/refractory multiple myeloma (RRMM) requires effective and safe treatment options.
- Lenalidomide plus dexamethasone is an established therapy for RRMM.
- Real-world data is crucial for understanding treatment safety beyond clinical trials.
Purpose of the Study:
- To evaluate the safety profile of lenalidomide plus dexamethasone in RRMM patients in a real-world European setting.
- To compare the safety of lenalidomide plus dexamethasone with other antimyeloma agents.
- To identify any new safety signals associated with lenalidomide treatment.
Main Methods:
- An observational, noninterventional European post-authorization safety study.
- Inclusion of 2150 patients initiating lenalidomide and 1479 initiating other therapies (predominantly bortezomib).
- Analysis of adverse events by incidence rates per 100 person-years.
Main Results:
- Lenalidomide showed lower incidence rates of neuropathy (10.5) and infections (68.7) compared to bortezomib and thalidomide.
- Higher incidence rates of neutropenia (38.0) and thrombocytopenia (24.4) were observed with lenalidomide compared to bortezomib.
- No new safety signals for lenalidomide were identified.
Conclusions:
- Lenalidomide plus dexamethasone demonstrates a comparable safety profile to clinical trial data in a real-world RRMM setting.
- The study represents the largest prospective real-world European investigation of lenalidomide in RRMM.
- Findings support the established safety and tolerability of lenalidomide in RRMM management.
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