Multiple Myeloma, Plasma Cell Leukemia
Conditions
Keywords
Bortezomib, PCL
Brief 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).
Detailed description
Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
Interventions
DRUGBortezomib
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.
DRUGDexamethasone
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
Harbin Hematology and Oncology Institute
Shanghai Changzheng Hospital
Chinese PLA General Hospital
307 Hospital of PLA
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Beijing Chao Yang Hospital
Henan Provincial People's Hospital
Peking University Third Hospital
Clinical Service, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | Day 1 of every treatment cycle | The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| partial remission rate | Day 1 of every treatment cycle | The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria. |
| duration of response | up to 6 months | — |
| the rate of response | Day 1 of every treatment cycle | The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria. |
| Adverse Events | up to two and a half years | Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0. |
| FACT/GOC-Ntx | Day 1 of every treatment cycle | — |
| overall survival | up to two and a half year | — |
Countries
China
Outcome results
None listed