Multiple Myeloma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGChidamide+VRD
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
DRUGVRD
Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this trial, patients will be randomly assigned to chidamide+VRD group or VRD group, and then treated with the corresponding regimen, and their safety and efficacy will be evaluated.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1.Diagnosed as multiple myeloma, and has one of the above: 1. high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或1q gain,1p-, double hit myeloma, triple hit myeloma, etc; 2. RISS-3; 3. IgD/IgE MM; 4. with measurable extra-medullary plasmacytoma; 5. flowcytometry showed peripheral blood plasma cell ≥0.165%； * 2.Secretory MM should have measurable markers, including: 1. specific M protein value (≥5g/L)； 2. and/or involved flc ≥100mg/L； 3. and/or measurable extramedullary foci (diameter\>1cm on CT); * 3.Age≥18 years, male or female; * 4.ECOG 0-2 points, with life expectance ≥3 months; GA score \<2; * 5.ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of normal maximum； * 6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L; * 7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy; * 8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1; * 9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators; * 10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.
Exclusion criteria
* 1.With ≥2 degree of peripheral neuropath or with pain; * 2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed; * 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction; * 4.Patients in pregnancy or lactation; * 5.Allergic constitution or being allergic to any drug within the regimen of the trial; * 6.With uncontrolled mental diseases; * 7.With active infection; * 8.With non-myeloma-associated acute renal dysfunction; * 9.With active hepatitis; * 10.HIV positive; * 11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma; * 12.With other conditions that the investigators think unfit for the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | at the time point 1 month after the last cycle | complete remission rate after treated by the corresponding regimen |
| incidence and severity of adverse events | from the date of the start of treatment to 36 months after last patient's enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment; | from date of inclusion to date of progression, relapse, or death from any cause |
| overall survival | from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment | from the date of inclusion to date of death, irrespective of cause |
Countries
China
Contacts
Primary ContactChengcheng Fu, PhD
Outcome results
None listed