A Phase I/II Trial of Romidepsin (Depsipeptide) and Bortezomib in Patients With Relapsed Myeloma

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

December 31, 2011

Study Completion Date

January 31, 2012

Conditions
Multiple Myeloma
Interventions
DRUG

depsipeptide

Cohort 1. Dose escalation, IV, Weeklyx3 in a 4week cycle. Cohort 2A. 12mg/m2, IV, Weeklyx3 in a 4week cycle. Cohort 2B. 12mg/m2, IV, Weeklyx2 in a 3week cycle.

DRUG

bortezomib

Cohort 1 and 2A. 3.5mg/m2, IV, day 1, 4, 8, 11 in 28 day cycle. Cohort 2B. 3.5mg/m2, IV, day 1, 4, 8, 11 in 21 day cycle

DRUG

dexamethasone

20mg for 2 days with each dose of bortezomib

Trial Locations (1)

8006

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Janssen-Cilag Ltd.

INDUSTRY

lead

Peter MacCallum Cancer Centre, Australia

OTHER