32
Participants
Start Date
September 1, 2008
Primary Completion Date
March 1, 2010
Study Completion Date
March 1, 2010
Bortezomib
"Bortezomib was administered at a dose of 1.0 mg/m\^2 as an intravenous (IV) push over 3 to 5 seconds twice weekly for 2 consecutive weeks (Days 1, 4, 8 and 11) of each 28-day cycle. On days that bortezomib and romidepsin were administered together, bortezomib was administered prior to the romidepsin infusion.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
Romidepsin
Romidepsin initially was administered at a dose of 10 mg/m\^2 as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle. Based on the occurrence of Grade 3 thrombocytopenia at this dose level, the dose was reduced by protocol amendment to 8 mg/m\^2.
Center for Cancer and Blood Disorders, Bethesda
Mecklenburg Medical Group, Charlotte
Georgia Cancer Specialists I, PC, Atlanta
Dallas Oncology Consultants, P.A., Duncanville
Baylor Sammons Cancer Center, Dallas
Oncology Consultants, P.A, Houston
Central Utah Clinic, PC, Provo
James R Berenson, MD, Inc., West Hollywood
Desert Cancer Care, Inc, Rancho Mirage
Loma Linda University Cancer Center, Loma Linda
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara
Virginia Mason Medical Centre, Seattle
Lead Sponsor
Celgene
INDUSTRY