Trial of Romidepsin and Bortezomib for Multiple Myeloma

PHASE2TerminatedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 1, 2008

Primary Completion Date

March 1, 2010

Study Completion Date

March 1, 2010

Conditions
Multiple Myeloma
Interventions
DRUG

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."

DRUG

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.

Trial Locations (12)

20817

Center for Cancer and Blood Disorders, Bethesda

28204

Mecklenburg Medical Group, Charlotte

30341

Georgia Cancer Specialists I, PC, Atlanta

75137

Dallas Oncology Consultants, P.A., Duncanville

75246

Baylor Sammons Cancer Center, Dallas

77024

Oncology Consultants, P.A, Houston

84604

Central Utah Clinic, PC, Provo

90069

James R Berenson, MD, Inc., West Hollywood

92270

Desert Cancer Care, Inc, Rancho Mirage

92354

Loma Linda University Cancer Center, Loma Linda

93105

Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara

98101

Virginia Mason Medical Centre, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY