50
Participants
Start Date
September 25, 2020
Primary Completion Date
December 30, 2025
Study Completion Date
December 30, 2025
bortezomib
The investigators gave patients subcutaneous bortezomib 1.3mg/m2 on days 1, 8,15, and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of bortezomib on days 1 and 15 at the dose level of 1.3mg/m2. Patients discontinued treatment if they had progressive disease or or unacceptable toxic effects not controlled with dose modifications.
Lenalidomide
The investigators gave patients oral lenalidomide 25mg on days 1 to 21 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of lenalidomide on days 1 to 21 at the dose level of 10mg. Patients discontinued treatment if they had progressive disease or unacceptable toxic effects not controlled with dose modifications.
Dexamethasone
The investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.
RECRUITING
Sun Yat-sen University Cancer Center, Guangzhou
Sun Yat-sen University
OTHER