In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China
RECRUITINGcomplete remission rate
complete remission rate after treated by the corresponding regimen
Time frame: at the time point 1 month after the last cycle
incidence and severity of adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of the start of treatment to 36 months after last patient's enrollment
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment;
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment
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