SRT501 +/- Bortezomib in patients with Multiple Myeloma

• Research type

  Research Study

• Full title

  A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma

• IRAS ID

  12477

• Sponsor organisation

  Sirtris Pharmaceuticals, Inc.

• Eudract number

  2008-005112-41

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Normally, new blood cells are produced to replace old cells in a controlled way. However, in multiple myeloma (MM) the process loses control and many abnormal plasma cells (myeloma cells) are produced. Plasma cells normally produce antibodies which fight infections. Myeloma cells produce abnormal antibodies that cannot fight infections. This can lead to MM patients being ill more frequently. Production of myeloma cells can also decrease other types of blood cells. Depending on the cells affected, MM patients may suffer from anaemia, abnormal bruising and bleeding.Myeloma cells can weaken bones leading to pain and fractures. Bones contain calcium. When this is released into the body patients may experience loss of appetite, constipation, sickness, depression and drowsiness. Also, as the disease spreads the spinal cord can become compressed leading to tingling, numbness and weakness in the feet and legs.MM can occur in both males and females; it is the second most commonly reported blood cancer and is usually fatal. Sirtuins are enzymes that affect cell growth under stress conditions. Experiments have shown that increasing levels of these enzymes can increase life expectancy and slow down cancer cell growth.Resveratrol is a natural chemical, found at high levels in some foods, that has been shown to increase the activity of Sirtuins. Natural resveratrol is not easily absorbed by the body and therefore SRT501 has been developed as an artificial form which can be taken as an oral medicine.Bortezomib (VelcadeTM) is a drug commonly used to treat MM.Combination of SRT501 and bortezomib in laboratory based experiments has shown that when used together they may become more effective.This study will assess whether it is safe for MM patients to take bortezomib and SRT501 together and whether taking SRT501, with or without bortezomib can increase the life expectancy of MM patients.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  09/H0808/14

• Date of REC Opinion

  17 Apr 2009

• REC opinion

  Further Information Favourable Opinion