Recruitment Complete
Sponsor ID
20180117

Study of Early relapsed, Lenalidomide-refractory subjects Eligible for Carfilzomib TripletSELECT

Sponsor ID
20180117
Clinicaltrials.gov ID
NCT04191616
EUCTIS ID
N/A
EudraCT ID
2019-001169-34

Study Details

A Study Evaluating Treatment of Multiple

Myeloma with Carfilzomib in Combination with

Pomalidomide and Dexamethasone

Additional Study Details

Phase
Phase 2
Product
Kyprolis
Type
Interventional
Masking
None (Open Label)
Enrollment
54
Additional Study Details

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
Status
Contact Us
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
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