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The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDD arm | Experimental | patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone ) |
|
| PAD arm | Active Comparator | patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone | Drug | doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | sCR + CR + VGPR | 4 cycles (each cycle is 28 days) of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall remission rate | sCR + CR | 4 cycles (each cycle is 28 days) of chemotherapy |
| Progression-free survival | 3 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | 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 |
|---|---|
| D003907 | Dexamethasone |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| PAD regimen: bortizomib, dexamethasone and doxorubicin | Drug | doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong) |
|
| Adverse Event |
| 3 year |
| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |