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KRd vs Rd in Newly Diagnosed Myeloma Patients Not Eligible for ASCT
NCT04096066Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2019
- Primary completion
- Sep 2027
- Countries
- 1
- Sponsor
- Fondazione EMN Italy
- Modality
- Irreversible Covalent Inhibitors, Reversible Covalent Inhibitors
- Drugs
- carfilzomib
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 3, randomised, open-label trial of carfilzomib in multiple myeloma (MM) (2 arms), sponsored by Fondazione EMN Italy. Primary endpoints: Minimal residual disease at 5 years and Progression-free survival at 5 years. Started Jul 2019; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
KRd (Experimental Arm)
Carfilzomib + Lenalidomide + Dexamethasone
Rd (Control Arm)
Lenalidomide + Dexamethasone
03
Who it enrols
Newly diagnosed symptomatic multiple myeloma patients aged >= 65 years, not eligible for ASCT, fit or intermediate frailty score, ECOG < 3, adequate organ function.
04
Endpoints
Primary
Minimal residual disease
Progression-free survival
Secondary
Rate of drug reduction or drug discontinuation
Cardiovascular assessment
Rate of dose reduction, drug discontinuation and toxicities
Response rate
Progression-free survival 2
Time to progression
Duration of response
Overall survival
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