Study Complete
Sponsor ID
20130314
A Phase 1 Study in Subjects with Relapsed or Refractory Multiple Myeloma
Study Details
This is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.
Protocol Summary
Primary Outcome Measures
Incidence of dose limiting toxicities (DLTs)
Timeframe: 3 years
Incidence of treatment-related adverse events
Timeframe: 3 years
Incidence of treatment-emergent adverse events
Timeframe: 3 years
Number of subjects with clinically significant changes in vital signs
Timeframe: 3 years
Number of subjects with clinically significant changes in physical examinations
Timeframe: 3 years
Number of subjects with clinically significant changes in ECGs
Timeframe: 3 years
Number of subjects with clinically significant changes in clinical laboratory tests
Timeframe: 3 years
Secondary Outcome Measures
Maximum observed concentration (Cmax)
Timeframe: 3 years
Minimum observed concentration (Cmin)
Timeframe: 3 years
Area under the concentration-time curve (AUC)
Timeframe: 3 years
Clearance (CL)
Timeframe: 3 years
Half-life (t1/2), if feasible
Timeframe: 3 years
Overall response according to International Myeloma Working Group (IMWG) uniform response criteria
Timeframe: 3 years
Time to progression (TTP)
Timeframe: 3 years
Duration of response (DOR)
Timeframe: 3 years
Conversion to MRD negativity
Timeframe: 3 years
Incidence of anti-AMG 224 antibody formation
Timeframe: 3 years
Locations
Location
Research Site
Prahran, VIC, Australia, 3181
Status
Recruiting
Location
Research Site
Boston, MA, United States, 02114
Status
Recruiting
Location
Research Site
West Hollywood, CA, United States, 90069
Status
Completed
Location
Research Site
Houston, TX, United States, 77030
Status
Recruiting
Location
Research Site
New York, NY, United States, 10065
Status
Recruiting