Trial Information
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall response rate
Outcome Description:
The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria
Outcome Time Frame:
Day 1 of every treatment cycle
Safety Issue:
No
Principal Investigator
zhao wang, Master
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beijing Friendship Hospital
Authority:
United States: Federal Government
Study ID:
26866138CAN2026
NCT ID:
NCT01328236
Start Date:
September 2010
Completion Date:
September 2015
Related Keywords:
- Plasma Cell Leukemia
- Multiple Myeloma
- Bortezomib
- PCL
- Leukemia
- Leukemia, Plasma Cell
- Multiple Myeloma
- Neoplasms, Plasma Cell