Lenalidomide

(Revlimid®)

Revlimid®

Drug updated on 11/4/2024

Dosage FormCapsule (oral; 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg)
Drug ClassThalidomide 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

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Summary
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  • 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 TitleYearSource
Revlimid (lenalidomide) Prescribing Information.2023Bristol-Myers Squibb, Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Meta-analysis of effectiveness and safety of proteasome inhibitor-dependent maintenance treatment for multiple myeloma a systematic review2024Heliyon
Efficacy of maintenance treatment in patients with multiple myeloma: a systematic review and network meta-analysis2022Hematology (Amsterdam, Netherlands)
Efficacy and Toxicity Profile of Carfilzomib-Based Regimens for Treatment of Newly Diagnosed Multiple Myeloma: A Systematic Review2021Oncotargets And Therapy
Thromboembolism Incidence and Risk Factors in Multiple Myeloma After First Exposure to Immunomodulatory Drug-Based Regimens2021Clinical Lymphoma, Myeloma & Leukemia
PK/PD modeling analysis for dosing regimen selection of isatuximab as single agent and in combination therapy in patients with multiple myeloma2021Cpt: Pharmacometrics & Systems Pharmacology
Lenalidomide as maintenance treatment for patients with multiple myeloma after autologous stem cell transplantation: A pharmaco-economic assessment2020European Journal Of Haematology
Bortezomib-based consolidation or maintenance therapy for multiple myeloma: a meta-analysis2020Blood Cancer Journal
Multiple drug combinations of bortezomib, lenalidomide, and thalidomide for first-line treatment in adults with transplant-ineligible multiple myeloma: a network meta-analysis2019The Cochrane Database Of Systematic Reviews
Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma2019Clinical Therapeutics
Upfront treatment for newly diagnosed transplant-ineligible multiple myeloma patients: A systematic review and network meta-analysis of 14,533 patients over 29 randomized clinical trials2019Critical Reviews In Oncology/Hematology

Clinical Practice Guidelines