Study Complete
Sponsor ID
CFZ013

Phase 1b Study of weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in subjects with Multiple Myeloma

Sponsor ID
CFZ013
Clinicaltrials.gov ID
NCT02335983
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
carfilzomib
Type
Interventional
Masking
None (Open Label)
Enrollment
107
Additional Study Details

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
Status
Contact Us
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
Showing {first} - {last} of {total} Results