Study Complete
Sponsor ID
CFZ013
Phase 1b Study of weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in subjects with Multiple Myeloma
Study Details
The purpose of the study is to assess the safety, tolerability and activity of a once-weekly regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.
Protocol Summary
Primary Outcome Measures
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 54 months
Laboratory Values
Timeframe: 54 months
Secondary Outcome Measures
Total Plasma Exposure - Area Under the Curve (AUC)
Timeframe: 58 months
Maximum plasma concentration (Cmax)
Timeframe: 58 months
Time to Maximum Plasma Concentration (Tmax)
Timeframe: 58 months
Total Plasma Clearance
Timeframe: 58 months
Plasma Terminal Half-life
Timeframe: 58 months
Overall Response Rate (ORR)
Timeframe: 58 months
Complete Response Rate (CRR)
Timeframe: 58 months
Progression-free survival (PFS)
Timeframe: 58 months
Duration of Response (DOR)
Timeframe: 58 months
Locations
Location
Research Site
Ann Arbor, MI, United States, 48109
Status
Recruiting
Location
Research Site
Bend, OR, United States, 97701
Status
Recruiting
Location
Research Site
Boston, MA, United States, 02114
Status
Recruiting
Location
Research Site
Charleston, SC, United States, 29424
Status
Recruiting
Location
Research Site
Cincinnati, OH, United States, 45242
Status
Recruiting
Location
Research Site
Fountain Valley, CA, United States, 92708
Status
Recruiting
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