A phase III study of LBH589 plus Bortezomib in multiple myeloma

• Research type

  Research Study

• Full title

  A multicenter, randomised, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma

• IRAS ID

  14136

• Contact name

  Jamie Cavenagh

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-015507-52

• ISRCTN Number

  n/a

• Research summary

  Multiple myeloma is a type of cancer that develops from cells in the bone marrow called plasma cells. It is an incurable disease and caused 2,695 deaths in the UK in 2007. Bortezomib and dexamethasone are drugs that have been in use for some time to treat patients with multiple myeloma. The purpose of this study is to find out whether the combination of panobinostat, bortezomib and dexamethasone is safe and results in a better anti-myeloma activity than bortezomib and dexamethasone alone. A study participant has a 1 to 1 chance of being treated with bortezomib and dexamethasone and panobinostat or bortezomib and dexamethasone and placebo (sugar pill). The placebo is used to make sure that the changes/benefits reported are not happening by chance. Patients will receive panobinostat/placebo for 48 weeks. It will be taken orally three times a week for two weeks followed by a one week break. All patients will recive treatment for the first 24 weeks and only patients who are benefiting from treatment will continue for the further 24 weeks. During the study patients will visit the study doctor on a regular basis for health checks, blood tests, bone marrow biopsy and ECG. A bone X-ray and either a cardiac ECHO or MUGA scan will be performed as part of the screening procedures. CT scans will be performed if the patients have plasmacytomas (lumps in their soft tissue) to see if these lumps decrease in size in responce to the treatment. An optional companion biomarker study is planned in selected trial sites to discover baseline biomarkers that will inform on tumour response to panobinostat. In addition, molecular CR will be investigated by DNA analysis.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/6

• Date of REC Opinion

  12 Mar 2010

• REC opinion

  Further Information Favourable Opinion