Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

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).

Conditions

• Plasma Cell Leukemia
• Multiple Myeloma

Interventions

DRUG

Bortezomib

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.

DRUG

Liposome doxorubicin

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.

DRUG

Dexamethasone

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.

Sponsors & Collaborators

• Harbin Hematology and Oncology Institute

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• 307 Hospital of PLA

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Clinical Service, China

  lead INDUSTRY

Principal Investigators

• zhao wang, Master · Beijing Friendship Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2013-09-30

Completion

2015-09-30

Countries

• China

Study Locations