Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Clinical Service, China
Sponsor:
Collaborators:
Harbin Institute of Hematology and Oncology
Shanghai Changzheng Hospital
Chinese PLA General Hospital
Affiliated Hospital to Academy of Military Medical Sciences
Wuhan Union Hospital, China
Beijing Chao Yang Hospital
Henan Provincial Hospital
Peking University Third Hospital
Information provided by (Responsible Party):
wangzhao, Clinical Service, China
ClinicalTrials.gov Identifier:
NCT01328236
First received: March 29, 2011
Last updated: September 21, 2011
Last verified: September 2011

March 29, 2011
September 21, 2011
September 2010
September 2013   (final data collection date for primary outcome measure)
overall response rate [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: up to two and a half year ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: up to two and a half years ] [ Designated as safety issue: Yes ]
    Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
  • FACT/GOC-Ntx [ Time Frame: Day 1 of every treatment cycle ] [ Designated as safety issue: Yes ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years to 75 Years
Yes
China
 
NCT01328236
26866138CAN2026
Yes
wangzhao, Clinical Service, China
Clinical Service, China
  • Harbin Institute of Hematology and Oncology
  • Shanghai Changzheng Hospital
  • Chinese PLA General Hospital
  • Affiliated Hospital to Academy of Military Medical Sciences
  • 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