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

Study Overview
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Brief Summary
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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).

Detailed Description
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Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores

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

Conditions
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Plasma Cell Leukemia, Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib
* Drug: Liposome doxorubicin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-DD single arm<br>INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. | Drug: Bortezomib<br>* 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.<br>* Other names: Velcade;Drug: Liposome doxorubicin<br>* 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.<br>* Other names: Caelyx;Drug: Dexamethasone<br>* 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.<br>* Other names: Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria | Day 1 of every treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of response | The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria. | 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. | Day 1 of every treatment cycle | 
| duration of response |  | up to 6 months | 
| overall survival |  | up to two and a half year | 
| Adverse Events | Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0. | up to two and a half years | 
| FACT/GOC-Ntx |  | Day 1 of every treatment cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bortezomib, PCL