Safety and Efficacy Study of GCS-100LE in the Treatment of Multiple Myeloma

PHASE1TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Multiple Myeloma
Interventions
DRUG

GCS-100

GCS-100 160mg/m2 IV (in the vein) on Study Days 1, 4, 8 and 11 for up to 12 consecutive 21-day treatment cycles. Three patients will be assigned to each cohort until maximum tolerated dose is reached. The dose levels: 1) 160 mg/m2; 2) 210 mg/m2; 3) 280 mg/m2; 4) 370 mg/m2

DRUG

Bortezomib/Dexamethasone

Bortezomid 1.3 mg/m2 and dexamethasone 20 mg/day plus an additional 20 mg of dexamethasone on the day following each of the GCS-100/bortezomib and dexamethasone dosing. GCS-100/bortezomib and dexamethasone dosed on Study Days 1, 4, 8 and 11 of each 21-day cycle after disease progression is noted.

Trial Locations (3)

32610

University of Florida, Gainesville

53226

Froedtert & Medical College Clinics, Medical College of Wisconsin, Milwaukee

02115

Dana Farber Cancer Institute, Boston

All Listed Sponsors
lead

La Jolla Pharmaceutical Company

INDUSTRY

NCT00609817 - Safety and Efficacy Study of GCS-100LE in the Treatment of Multiple Myeloma | Biotech Hunter | Biotech Hunter