Recruitment Complete
Sponsor ID
20180117
Study of Early relapsed, Lenalidomide-refractory subjects Eligible for Carfilzomib TripletSELECT
Study Details
A Study Evaluating Treatment of Multiple
Myeloma with Carfilzomib in Combination with
Pomalidomide and Dexamethasone
Protocol Summary
Primary Outcome Measures
Overall response rate (ORR)
Timeframe: 12 months
Secondary Outcome Measures
Number of participants with a minimal residual disease negative complete response (MRD[-]CR) in participants with multiple myeloma at first or second relapse after treatment with lenalidomide
Timeframe: Up to 13 months
Subject incidence of treatment-emergent adverse event
Timeframe: Up to 60 Months
Number of participants who achieve minimal residual disease negative (MRD[-]) after treatment with pomalidomide and dexamethasone (KPd)
Timeframe: Up to 60 months
Number of participants with sustained MRD[-]CR
Timeframe: 26 months
Number of participants with sustained MRD[-]CR
Timeframe: 24 months
Duration of response (DOR)
Timeframe: From start of treatment until disease progression or death from any cause (approximately 5 years)
Time to response (TTR)
Timeframe: From start of treatment until disease progression or death from any cause (approximately 5 years)
Progression-free survival (PFS)
Timeframe: From start of treatment until disease progression or death from any cause (approximately 5 years)
Overall survival (OS)
Timeframe: From start of treatment until disease progression or death from any cause (approximately 5 years)
Best overall confirmed response of CR or better
Timeframe: Up to 60 months
Locations
Location
General Hospital Evangelismos
Athens, Greece, 10676
Status
Recruiting
Location
University General Hospital of Evros-Alexandroupolis District
Alexandroupoli, Greece, 68100
Status
Recruiting
Location
Alexandra Hospital
Athens, Greece, 11528
Status
Recruiting
Location
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki, Greece, 54007
Status
Recruiting
Location
General University Hospital of Patras Panagia i Voithia
Patra, Greece, 26504
Status
Recruiting
Location
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, Italy, 60126
Status
Recruiting
Showing {first} - {last} of {total} Results