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

• the rate of response [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: No ]
  The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
• partial remission rate [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: No ]
  The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
• duration of response [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
• overall survival [ Time Frame: up to two and a half year ] [ Designated as safety issue: No ]
• Adverse Events [ Time Frame: up to two and a half years ] [ Designated as safety issue: Yes ]
  Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
• FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: Yes ]

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

• Plasma Cell Leukemia
• Multiple Myeloma

• 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.

  Other Name: Velcade
• 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.
  Other Name: Caelyx
• 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.

  Other Name: Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon

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

• Harbin Institute of Hematology and Oncology
• Shanghai Changzheng Hospital
• Chinese PLA General Hospital
• Affiliated Hospital to Academy of Military Medical Sciences
• Wuhan Union Hospital, China
• Beijing Chao Yang Hospital
• Henan Provincial Hospital
• Peking University Third Hospital