drugset
drugset / Trial / NCT02891811

Patients With Newly Diagnosed Multiple Myeloma Comparing KTd vs. KRd Induction Therapy and Investigating a K-mono Maintenance Strategy

NCT02891811 ↗

Phase 2 Completed 124 enrolled Study Group of Medical Tumour Therapy (AGMT) Amgen · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, 2-arm phase II, multi-center study to evaluate the overall response rate in newly diagnosed, transplant ineligible patients receiving 9 cycles induction therapy with either KTd or KRd followed by randomization to either carfilzomib maintenance treatment for 12 months or to observation only. Maintenance is given for 12 cycles or progression of disease, whatever occurs first.

Timeline

Start
2017-03-10
Primary completion
2024-03-28
Completion
2024-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 20 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 27 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 56 mg/m2 Intravenous
Comparator Lenalidomide Other / unclassified 25 mg Oral
Subject Thalidomide Other / unclassified 50 mg Oral
Subject Thalidomide Other / unclassified 100 mg Oral
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral

Indications

plasma cell myeloma