title: The clinical safety of  lenalidomide  in multiple myeloma and myelodysplastic syndromes.
abstract: BACKGROUND
  Lenalidomide is an IMiDs® oral immunomodulatory compound developed for the treatment of patients with multiple myeloma (MM) and myelodysplastic syndromes (MDS). Long-term continuous treatment with lenalidomide beyond first response may be important to optimize responses and delay relapse.
  
  
  METHODS
  This review summarizes the lenalidomide mechanism of action, pharmacodynamics, key clinical studies with a focus on safety and post-marketing surveillance data. The necessity for early adverse-event management, including dose modifications for neutropenia and thrombocytopenia, and venous thromboembolism prophylaxis, where applicable, in order to maintain patients on treatment and achieve optimal efficacy, is discussed. Secondary primary malignancies in MM and progression to acute myeloid leukemia in MDS patients in the context of lenalidomide treatment are also discussed. Finally, as lenalidomide is renally excreted, the requirement for dose adjustment according to creatinine clearance is discussed.
  
  
  CONCLUSIONS
  Lenalidomide is highly effective and generally well tolerated. Most adverse events occur early during the course of treatment and are manageable. Lenalidomide is not associated with peripheral neuropathy and has a lack of cumulative toxicity, making it an effective treatment option for long-term use in the management of MM and low/intermediate-1-risk MDS, specifically with chromosome 5q deletion with or without other cytogenetic abnormalities.
authors: Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera San Giovanni Battista, Via Genova 3, 10126 Turin, Italy. appalumbo@yahoo.com
authors: Antonio
authors: A
authors: Palumbo
authors: John
authors: J
authors: Freeman
authors: Lilia
authors: L
authors: Weiss
authors: Pierre
authors: P
authors: Fenaux
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D006801:Humans; D000077269:Lenalidomide; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000473:pathology; D011358:Product Surveillance, Postmarketing; D051437:Renal Insufficiency / Q000150:complications; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide