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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide plus VRD | Experimental | 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 |
|
| VRD | Active Comparator | Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide+VRD | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | complete remission rate after treated by the corresponding regimen | 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 | from the date of the start of treatment to 36 months after last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment; |
| overall survival |
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Inclusion Criteria:
1.Diagnosed as multiple myeloma, and has one of the above:
2.Secretory MM should have measurable markers, including:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengcheng Fu, PhD | Contact | 13962191404 | fuzhengzheng@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| chengcheng Fu, PhD | First Affiliated Hospital of Suzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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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.
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| VRD | Drug | Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14 |
|
from the date of inclusion to date of death, irrespective of cause
| from the day of treatment to the date of first documented progression,up to 36 months after the last patient's enrollment |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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