34
Participants
Start Date
August 31, 2011
Primary Completion Date
December 31, 2015
Study Completion Date
December 31, 2015
Vorinostat
"Vorinostat 100 mg/d p.o., on day 1-4, 8-11, and 15-18 /28 day treatment cycle in combination with BDD.~The dose level of Vorinostat will be escalated in each new cohort:~if no dose limiting toxicity (DLT) has been observed in the previous dose level in 3 patient, the second cohort of 3 new patients will be treated with Vorinostat 200 mg/d p.o. and the third cohort will be given Vorinostat with 300 mg/d p.o."
Bortezomib
1.3mg/m2 (days 1,8,15)/28 day treatment cycle, i.v., for max. 6 treatment cycles
Doxorubicin
18mg/m2 i.v. (days 1 and 8)/ 28 day treatment cycle, max. 6 treatment cycles
Dexamethasone
40mg abs. p.o. (days 1,8,15,22) 1st treatment cycle, 20mg abs. p.o.(days 1,8,15,22) 2-6 treatment cycles
University Medical Center Freiburg, Freiburg im Breisgau
Merck Sharp & Dohme LLC
INDUSTRY
Janssen-Cilag Ltd.
INDUSTRY
University Hospital Freiburg
OTHER