The RENEW trial, Phase 3, Lenalidomide in Mantle Cell Lymphoma

• Research type

  Research Study

• Full title

  A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, FIRST LINE MAINTENANCE STUDY OF LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH MANTLE-CELL LYMPHOMA

• IRAS ID

  39092

• Contact name

  Simon Alexander Joseph Rule

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2008-006177-32

• 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). 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 are not candidates for transplantation and have achieved partial response or complete response after completion of first-line combination chemotherapy. 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 382 subjects from across Europe and America. The study will last approximately 2 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, a pharmaceutical company.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  10/H0206/22

• Date of REC Opinion

  15 Jul 2010

• REC opinion

  Further Information Favourable Opinion