Clinical trials

EMN20

11/01/2019

CARFILZOMIB - LENALIDOMIDE - DEXAMETHASONE (KRd) versus LENALIDOMIDE - DEXAMETHASONE (Rd) IN NEWLY DIAGNOSED MYELOMA PATIENTS NOT ELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION: A RANDOMIZED PHASE III TRIAL

After enrollment, patients are randomized in two different groups, in order to receive continuous treatment with either carfilzomib-lenalidomide-dexamethasone (KRd) or lenalidomide-dexamethasone (Rd). Patients in both arms receive continuous treatment until any sign of progression or intolerance. After 2 years, carfilzomib administration is stopped after achieving minimal residual disease negativity (MRD; post 12 and post 24 months).

STUDY OBJECTIVES

Primary objectives

To compare the efficacy of KRd vs. Rd in terms of progression-free survival.
To compare the efficacy of KRd vs. Rd in terms of 2-year MRD negativity.

Secondary objectives

To compare the safety of KRd vs. Rd in patients with newly diagnosed symptomatic multiple myeloma.
To evaluate the efficacy of treatment with KRd in terms of long-term objectives, i.e. time prior to second-line therapy and survival.

STUDY POPULATION

Newly diagnosed multiple myeloma patients older than 65 years of age or younger patients who are ineligible for high-dose therapy.

STUDY DRUGS

Carfilzomib
Lenalidomide
Dexamethasone

TOTAL SAMPLE SIZE: 340 patients

ACCRUAL TIME: 24 months

Study type: New Diagnosis
Enrollment: Open
Study phase:
Phase 3
Sponsor: EMN Italy Foundation