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

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Clinical Service, China
• Collaborators: 307 Hospital of PLA; Beijing Chao Yang Hospital; Chinese PLA General Hospital; Harbin Hematology and Oncology Institute; Harbin Institute of Hematology and Oncology; Henan Provincial Hospital; Henan Provincial People's Hospital; Peking University Third Hospital; Shanghai Changzheng Hospital; Wuhan Union Hospital, China
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib

• KPS ≥ 60

• Adequate liver and renal function within 2 weeks of Screening:

• Bilirubin ≤ 1.5 × the upper limit of normal (ULN)

• Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)

• Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)

• Cardiac function > Ⅲ grade and ejection fraction > 45%

• Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care

Exclusion Criteria:

• has taken Bortezomib

• KPS ≤ 60 scores

• mental illness