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| Name | Class |
|---|---|
| Harbin Hematology and Oncology Institute | OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| 307 Hospital of PLA |
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Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).
The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).
Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).
Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-DD single arm | Experimental | INDUCTION THERAPY: V-DD induction therapy for 6 cycles,28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,(Specially for IgA type). Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1, 4, 8, 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1, 4, 8, 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria | Day 1 of every treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of response | The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria. | Day 1 of every treatment cycle |
| partial remission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhao wang, Master | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Clinical Service Center | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D007952 | Leukemia, Plasma Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| C506643 | liposomal doxorubicin |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Peking University Third Hospital | OTHER |
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|
|
| Liposome doxorubicin | Drug | INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. |
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|
| Dexamethasone | Drug | INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. |
|
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The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
| Day 1 of every treatment cycle |
| duration of response | up to 6 months |
| overall survival | up to two and a half year |
| Adverse Events | Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0. | up to two and a half years |
| FACT/GOC-Ntx | Day 1 of every treatment cycle |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |