Drug updated on 12/11/2024
| 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.
Latest News
Summary
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- Lenalidomide significantly prolonged overall survival (OS) compared to placebo, with odds ratios (OR) ranging from 1.61 to 1.99. The lenalidomide-carfilzomib combination showed even greater efficacy in OS, with OR ranging from 3.19 to 6.95 compared to lenalidomide alone (OR 2.18 to 2.20) and other agents like daratumumab and ixazomib (OR 1.49 to 2.66 and 2.75 to 3.57, respectively).
- Lenalidomide and its combinations demonstrated significant improvements in progression-free survival (PFS) compared to placebo, with maintenance therapy post-autologous stem cell transplantation (ASCT) extending PFS and delaying relapse.
- The combination of lenalidomide with carfilzomib resulted in superior overall response rates (ORR) and complete response (CR) rates when compared to other treatment regimens.
- Lenalidomide, particularly in combination with agents like carfilzomib and dexamethasone, was found to be highly effective and superior to combinations such as bortezomib-lenalidomide.
- Lenalidomide was associated with significant adverse events, including hematological toxicity, thromboembolism (TE), and cardiovascular events, with hematological toxicity being the most common adverse event observed in lenalidomide-based regimens.
- The risk of thromboembolism with lenalidomide, with or without dexamethasone, was influenced by factors such as male sex and comorbidities, though the risk did not significantly differ between thromboprophylaxis groups.
- In comparisons with bortezomib, lenalidomide showed a lower incidence of neuropathy but a higher incidence of cardiovascular and thromboembolic events. Additionally, lenalidomide combinations presented an increased risk of grade 3-4 adverse events, particularly hematological and cardiovascular events.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Revlimid (lenalidomide) Prescribing Information. | 2023 | Bristol-Myers Squibb, 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 |