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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
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.
Beijing Clinical Service Center
Beijing, Beijing Municipality, China
RECRUITINGoverall response rate
The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria
Time frame: Day 1 of every treatment cycle
the rate of response
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
Time frame: Day 1 of every treatment cycle
partial remission rate
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
Time frame: Day 1 of every treatment cycle
duration of response
Time frame: up to 6 months
overall survival
Time frame: up to two and a half year
Adverse Events
Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
Time frame: up to two and a half years
FACT/GOC-Ntx
Time frame: Day 1 of every treatment cycle
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