drugset / Trial / NCT01328236
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Phase 2
Unknown
20 enrolled
Clinical Service, China
307 Hospital of PLA · collabBeijing Chao Yang Hospital · collabChinese PLA General Hospital · collabHarbin Hematology and Oncology Institute · collabHenan Provincial People's Hospital · collabPeking University Third Hospital · collabShanghai Changzheng Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
NaSingle-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2010-09
- Primary completion
- 2013-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |