Clinical Trial

Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in High- Risk SMM

Study acronym: HO147SMM
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated November 1, 2023 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.
Summary
Randomized (2:1) multi-center open-label phase II trial. Patients with high-risk SMM will be enrolled on the study and treated with KRd combination (Cycles 1-9 carfilzomib 20/36 mg/m2, lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9) or Rd combination (Cycles 1-9 lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9); followed by extended lenalidomide dosing (10 mg days 1-21 of a 28 day cycle for 24 cycles).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2018-09-14; most recent amendment 2023-10-31.
Status change: Recruiting → Active, Not Recruiting 2023-10-31
Status change: Not Yet Recruiting → Recruiting 2018-11-19
Trial Details
NCT Number NCT03673826
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions Smouldering Myeloma
Enrollment 58 participants
Start Date 2018-11-19
Primary Completion 2024-08 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2023-11-01