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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by wangzhao, Clinical Service, China.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328236
First Posted: April 4, 2011
Last Update Posted: September 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Harbin Hematology and Oncology Institute
Shanghai Changzheng Hospital
Chinese PLA General Hospital
307 Hospital of PLA
Wuhan Union Hospital, China
Beijing Chao Yang Hospital
Henan Provincial Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
wangzhao, Clinical Service, China
March 29, 2011
April 4, 2011
September 22, 2011
September 2010
September 2013   (Final data collection date for primary outcome measure)
overall response rate [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01328236 on ClinicalTrials.gov Archive Site
  • the rate of response [ Time Frame: 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.
  • partial remission rate [ Time Frame: 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 [ Time Frame: up to 6 months ]
  • overall survival [ Time Frame: up to two and a half year ]
  • Adverse Events [ Time Frame: up to two and a half years ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
  • FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ]
  • the rate of response [ Time Frame: 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.
  • partial remission rate [ Time Frame: 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 [ Time Frame: up to 6 months ]
  • overall survival [ Time Frame: up to two and a half year ]
  • Adverse Events [ Time Frame: up to the end of the treatment (up to two and a half years) ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
  • FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ]
Not Provided
Not Provided
 
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Plasma Cell Leukemia
  • Multiple Myeloma
  • Drug: Bortezomib

    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.

    Other Name: Velcade
  • Drug: Liposome doxorubicin
    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.
    Other Name: Caelyx
  • Drug: Dexamethasone

    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.

    Other Name: Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon
Experimental: V-DD single arm

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.

Interventions:
  • Drug: Bortezomib
  • Drug: Liposome doxorubicin
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
September 2015
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01328236
26866138CAN2026
Yes
Not Provided
Not Provided
wangzhao, Clinical Service, China
Clinical Service, China
  • Harbin Hematology and Oncology Institute
  • Shanghai Changzheng Hospital
  • Chinese PLA General Hospital
  • 307 Hospital of PLA
  • Wuhan Union Hospital, China
  • Beijing Chao Yang Hospital
  • Henan Provincial Hospital
  • Peking University Third Hospital
Principal Investigator: zhao wang, Master Beijing Friendship Hospital
Clinical Service, China
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP