MUK six

• Research type

  Research Study

• Full title

  A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients

• IRAS ID

  103744

• Contact name

  Jamie Cavenagh

• Sponsor organisation

  University of Leeds

• Eudract number

  2012-000842-36

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Multiple myeloma (MM) is a malignant disorder of bone marrow plasma cells. It affects over 4,500 new individuals each year in the UK and is presently incurable. High dose chemotherapy is associated with a median survival of 4.5 years, but all patients eventually relapse. Despite the introduction of a number of novel target specific treatments, including thalidomide, lenalidomide and bortezomib, all patients become resistant to these, and new therapies are required. Velcade (bortezomib), thalidomide and dexamethasone (VTD) has been demonstrated to be a highly effective combination in both patients with previously untreated and those with relapsed multiple myeloma. In previously untreated patients VTD demonstrated clear superiority to TD as induction therapy prior to planned tandem autologous stem cell transplant. The rationale of this trial is to combine a ??gold standard?? anti-MM combination with the HDAC inhibitor Panobinostat. There is emerging data to support the concept of clinical synergy between BTZ and HDACi??s. The purpose of this study is to determine the maximum tolerated dose (MTD) and estimated response rates of panobinostat, administered in combination with VTD, in subjects with relapsed and relapsed/refractory multiple myeloma.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  12/LO/0965

• Date of REC Opinion

  11 Jul 2012

• REC opinion

  Favourable Opinion