Study Complete
Sponsor ID
20130314

A Phase 1 Study in Subjects with Relapsed or Refractory Multiple Myeloma

Sponsor ID
20130314
Clinicaltrials.gov ID
NCT02561962
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.

Additional Study Details

Phase
Phase 1
Product
AMG 224
Type
Interventional
Masking
None (Open Label)
Enrollment
42
Additional Study Details

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
Status
Contact Us
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