Drug updated on 4/17/2024
| Dosage Form | Capsule (oral; 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg) |
| Drug Class | Thalidomide analogues |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of multiple myeloma (MM), in combination with dexamethasone.
- Indicated for the treatment of MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
- Indicated for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
- Indicated for the treatment of mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
- Indicated for the treatment of previously treated follicular lymphoma (FL), in combination with a rituximab product.
- Indicated for the treatment of previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.
Summary
- Lenalidomide is indicated for the treatment of multiple myeloma, particularly in combination with dexamethasone and ixazomib, where it has shown significantly longer progression-free survival compared to other treatments. It also shows potential benefits as a maintenance therapy in chronic lymphocytic leukemia by extending progression-free survival.
- Eight systematic reviews/meta-analyses covered various indications for lenalidomide, including multiple myeloma, CLL, DLBCL, and lupus, among others.
- In patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), lenalidomide monotherapy showed activity and tolerability. However, better responsiveness was observed specifically in patients of the non-GCB phenotype, indicating subgroup-specific efficacy.
- For newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients, maintenance therapy with lenalidomide did not show significant benefit in overall survival, suggesting its limited role due to lack of clear survival benefits.
- The studies highlighted that triplet therapies containing monoclonal antibodies are superior for treating cases of lenalidomide-refractory multiple myeloma, demonstrating its limited utility but highlighting the efficacy of mAb-containing regimens within this patient subgroup.
- Despite thromboprophylaxis measures taken into account during clinical trial settings involving multiple myeloma patients on a regimen based on lenalidomide, there still exists a substantial risk associated with venous thromboembolism, calling out the need for further strategies to mitigate this risk, especially when dealing with high VTE risk regimens.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Revlimid (lenalidomide) Prescribing Information. | 2023 | Bristol-Myers Squibb Company, Princeton, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| ASTCT clinical practice recommendations for transplantation and cellular therapies in multiple myeloma. | 2022 | Transplantation and Cellular Therapy |
| Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
| Newly diagnosed and relapsed follicular lymphoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |
| Multiple myeloma, version 3.2021. | 2020 | Journal of the National Comprehensive Cancer Network |
| Chronic lymphocytic leukemia/small lymphocytic lymphoma, version 4.2020. | 2020 | Journal of the National Comprehensive Cancer Network |
| The clinical management of lenalidomide-based therapy in patients with newly diagnosed multiple myeloma. | 2020 | Annals of Haematology |
| Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. | 2019 | Journal of Clinical Oncology |