Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE)
Condition: Cutaneous Lupus Erythematosus (CLE)
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the safety and effectiveness of lenalidomide
      (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used
      in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age
      of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will
      be included in the study.
    

Detailed description: 
      Cutaneous lupus erythematosus (CLE) is a chronic and often disabling disease which affects
      the skin. Many patients experience scarring and inflammation of the skin, which often occur
      on the face. Moderate to severe CLE is most frequently treated with antimalarial drugs such
      as hydroxychloroquine, quinacrine or chloroquine. Up to 70% of CLE patients treated with
      antimalarials experience a beneficial clinical response, while the remainder of patients show
      no response or continue to experience progression of the disease. Thalidomide has been used
      successfully in such patients, with up to 75% clinical response rate in refractory CLE
      patients. However, thalidomide is a known teratogen and can cause severe birth defects,
      including short, malformed limbs and damage to peripheral nerves in the extremities,
      requiring patients to be monitored for pregnancy. In addition, up to 25% of patients on
      thalidomide develop peripheral neuropathy. A new drug, lenalidomide (REVLIMID®), an analogue
      of thalidomide, has been developed to treat neoplastic and inflammatory conditions, including
      various oncologic conditions such as multiple myeloma, myelodysplastic syndrome and solid
      tumors. Unlike thalidomide, lenalidomide (REVLIMID®) is not known to cause the extent of
      serious side effects caused by thalidomide; however, it must also be monitored for side
      effects and be distributed under the RevAssist program authorized by the drug manufacturer,
      Celgene Corporation.

      The primary goal of this investigator-initiated, small pilot study is to evaluate the safety
      and effectiveness of lenalidomide (REVLIMID®) in CLE subjects using measurements such as the
      CLASI (Cutaneous Lupus Activity and Severity Index). The study drug will be used in an
      off-label indication to treat 6 subjects, for whom lenalidomide (REVLIMID®) will be provided
      at no cost by the drug manufacturer. Men and women over the age of 18, who have a biopsy
      proven diagnosis of refractory CLE and who have failed standard treatment with
      hydroxychloroquine for up to three months, will be included in the study. Secondarily, the
      study will evaluate the biologic effects of lenalidomide on pathogenic and immunologic
      mechanisms of the CLE disease process during the treatment period by collecting skin
      specimens (biopsies) and blood samples.
    

Intervention name(s): Lenalidomide
Intervention type(s): Drug
Intervention MeSH terms: Lenalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous Lupus Erythematosus; CLE; lenalidomide; revlimid; thalidomide derivative; drug; lupus