The "Emerge" Trial. A phase 2 study of lenalidomide.

• Research type

  Research Study

• Full title

  A Phase II Multicenter, single-arm, open-label study to determine the efficacy and safety of single-agent, lenalidomide (Revlimid®) in subjects with Mantle Cell Non-Hodgkin’s Lymphoma who have relapsed or progressed after treatment with Bortezomib or are refractory to bortezomib

• IRAS ID

  22043

• Contact name

  Anton R Kruger

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2007-007756-34

• ISRCTN Number

  Unknown

• Research summary

  This study is being conducted to investigate a new drug, called Lenalidomide, in patients with mantle cell lymphoma (a type of cancer of the lymph nodes that affects the white blood cells) who have had a return in their disease or no response after initial therapy. For patients with this disease the prognosis is poor and there is no clear consensus on how such patients should be treated. Relapses (return in disease) occur eventually in most patients and despite initial responses, the remission (absence of disease) durations are short. Therefore it is clear the need for novel innovative approaches and it is hoped that this study will help to determine if lenalidomide is a safe and effective treatment in patients who have relapsed (return in disease) or progressed (worsening of disease) after treatment with bortezomib or are refractory (lack of response to treatment) to bortezomib. Lenalidomide is a type of drug known as an immunomodulatory, IMiD?½ drug (a drug that affects the immune system). Lenalidomide can change the body's immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. This study will involve approximately 133 subjects from across Europe and America. The study will last approximately 2 and a half years. Patients will continue to receive treatment as long as the study drug helps and they do not experience side effects that cannot be controlled or if the patients voluntarily decides to stop study drug treatment. This study is sponsored by Celgene Corporation.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/27

• Date of REC Opinion

  4 Aug 2009

• REC opinion

  Further Information Favourable Opinion