drugset / Trial / NCT04096066

A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant

NCT04096066

Phase 3 Active not recruiting 84 enrolled Fondazione EMN Italy Onlus
RandomizedParallel-groupOpen-labelTreatment

Summary

The combination of lenalidomide plus low-dose dexamethasone (Rd) is considered the new standard for elderly newly diagnosed multiple myeloma (NDMM) patients. The combination carfilzomib plus lenalidomide-dexamethasone (KRd) in relapsed-refractory MM patients improved the progression-free survival (PFS) of approximately 1 year compared to standard Rd treatment. In a small phase 2 trial (23 pts) the KRd combination in elderly NDMM pts showed a complete response (CR) rate of 79% and a PFS at 3 years of 80%. Cardiovascular adverse events are the most limiting toxicities, especially in elderly patients.

Timeline

Start
2019-07-01
Primary completion
2026-01-01
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 56 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral
Background Lenalidomide Other / unclassified 25 mg Oral

Indications