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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Plasma Cell Leukemia, Multiple Myeloma

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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

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