drugset / Trial / NCT03809780

Study to Demonstrate Clinical Benefit of Lenalidomide and Dexamethasone

NCT03809780 ↗

NaSingle-groupOpen-labelTreatment

Summary

Recent prospective multicenter phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15mg) and dexamethasone (20mg) in frail patients with relapsed or refractory MM. The overall response rate was 71% including complete remission of 15%. Median progression free survival and overall survival were 8.9 and 30.5 months. In addition, grade 3-4 toxicities such as neutropenia, and infections were reduced. This study supported that lower dose lenalidomide may be optimal stating dose for elderly patients with frailty.

Timeline

Start
2019-03-11
Primary completion
2024-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 10 mg —
Subject Dexamethasone Small molecule 20 mg —
Subject Lenalidomide Other / unclassified 15 mg —
Subject Lenalidomide Other / unclassified 25 mg —

Indications