Randomised study of vorinostat in patients with Multiple Myeloma

• Research type

  Research Study

• Full title

  An International, Multicentre, Randomised, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma

• IRAS ID

  7082

• Contact name

  Majid A Kazmi

• Sponsor organisation

  Merck & Co., Inc.

• Eudract number

  2008-003752-30

• ISRCTN Number

  N/A

• Research summary

  Multiple myeloma (MM) is a cancer that begins in plasma cells found in the bone marrow. Abnormal plasma cells grow out of control and produce abnormal immunoglobulins, causing bone and kidney damage and suppression of the normal bone marrow and immune system. Although the median survival of patients with multiple myeloma has improved in the last years thanks to the availability of new treatment options, the disease remains largely incurable. This highlights the importance of developing new treatments in particular for patients with very advanced disease no longer responding to any of the standard of care available to them.Previous studies in the lab and 2 small studies in patients have shown that adding vorinostat to bortezomib treatment can have clinically important benefits in patients with this disease. These findings strongly support the development of vorinostat, in combination with bortezomib, for the treatment of MM.This study is a global phase III trial enrolling patients with relapsed or refractory multiple myeloma. All patients will be randomised to receive either bortezomib plus vorinostat or bortezomib plus matching placebo till disease progression, unacceptable toxicity or consent withdrawal. Treatments will be given in cycles which are 21 day repeating periods. Patients will attend regular clinic visits for standard medical care, to give blood and urine samples, maybe have an x-ray or scan to show their disease status and asked questions about their health.The participating sites will be located in North America, Europe, Asia-pacific and Latin America countries.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  08/H0505/202

• Date of REC Opinion

  13 May 2009

• REC opinion

  Further Information Favourable Opinion