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Brief Title: Velcade, Thalidomide, Dexamethasone and Panobinostat Treatment and Panobinostat Maintenance in Multiple Myeloma
Official Title: A Phase I/IIa Trial of VTD-panobinostat Treatment and Panobinostat Maintenance in Relapsed and Relapsed/Refractory Multiple Myeloma Patients
Study ID: NCT02145715
Brief Summary: 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' antiMM 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Birmingham Heartlands Hospital, Birmingham, UK, United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Guy's Hospital, London, , United Kingdom
Name: Jamie Cavenagh, MRCPath
Affiliation: St. Bartholomew's Hospital
Role: PRINCIPAL_INVESTIGATOR