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| Name | Class |
|---|---|
| Chipscreen Biosciences, Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of combination of Chidamide-Lenalidomine-Dexamethasone in relapsed or refractory multiple myeloma patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRD regimen | Experimental | CRD is a new 3-drug regimen adding a HDACi named chidamide to a novel 2-drug combination of lenalidomide and dexamethasone (RD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chidamide | Drug | 20 mg/d, will be administered orally, on Days 1, 4, 8, 11 of each 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | according to IMWG criteria, including the rate of complete remission (CR), very good partial remission (VGPR) and partial remission (PR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | as assessed by CTCAE v4.0 | 2 years |
| Overall Survival Rate | The percentage of people in the study group who are still alive 2 years after the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Wei, MD | Contact | 00862164041990 | 2925 | wei.zheng@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peng Liu, MD,PhD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C000613826 | HBI-8000 |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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All the patients involved in this study will receive a 3-drug regimen (chindamide, lenalidomide and dexamethasone)
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| lenalidomide | Drug | 25 mg/d, will be administered orally on Days 1-14 each 21 day cycle |
|
| dexamethasone | Drug | 40mg weekly, will be administered orally or intravenously |
|
| 2 years |
| 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 |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |