Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma

PHASE1TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Multiple Myeloma
Interventions
DRUG

Arsenic Trioxide, Ascorbic Acid and Bortezomib

"Phase I/Cohort I~Loading:~1. Arsenic Trioxide (ATO): 0.25 mg/kg IV over 1-2 hr qd x 5 days (Monday-Friday)~2. Ascorbic Acid: 1000 mg by IV infusion over 15 minutes after each infusion of arsenic trioxide qd x 5 days~Maintenance cycles (21 days)~1. ATO: 0.25 mg/kg IV over 1-2 hr once a week x 2 weeks every 3 weeks (one cycle) for a total of 6 cycles.~2. Ascorbic Acid 1000mg IV will be given within 30 minutes of completion of ATO.~3. Bortezomib 1 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 8 of a 21-day cycle. ATO is given at least one hour prior to Bortezomib. The first cycle will start on week 2, after loading dose week.~Phase I/Cohort 1 is followed by Cohort 2. Phase II uses maximum tolerated dose from Phase I."

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cephalon

INDUSTRY

lead

Duke University

OTHER

NCT00590603 - Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter