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

Primary Purpose

Plasma Cell Leukemia, Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Liposome doxorubicin
Dexamethasone
Sponsored by
Clinical Service, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasma Cell Leukemia focused on measuring Bortezomib, PCL

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beijing Clinical Service CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V-DD single arm

Arm Description

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.

Outcomes

Primary Outcome Measures

overall response rate
The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria

Secondary Outcome Measures

the rate of response
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
partial remission rate
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
duration of response
overall survival
Adverse Events
Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
FACT/GOC-Ntx

Full Information

First Posted
March 29, 2011
Last Updated
September 21, 2011
Sponsor
Clinical Service, China
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 People's Hospital, Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01328236
Brief Title
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Acronym
Bortezomib
Official Title
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Service, China
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 People's Hospital, Peking University Third Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Leukemia, Multiple Myeloma
Keywords
Bortezomib, PCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V-DD single arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposome doxorubicin
Other Intervention Name(s)
Caelyx
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall response rate
Description
The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria
Time Frame
Day 1 of every treatment cycle
Secondary Outcome Measure Information:
Title
the rate of response
Description
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
Time Frame
Day 1 of every treatment cycle
Title
partial remission rate
Description
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
Time Frame
Day 1 of every treatment cycle
Title
duration of response
Time Frame
up to 6 months
Title
overall survival
Time Frame
up to two and a half year
Title
Adverse Events
Description
Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
Time Frame
up to two and a half years
Title
FACT/GOC-Ntx
Time Frame
Day 1 of every treatment cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhao wang, Master
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Clinical Service Center
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhao wang, M.D
Phone
861063138303
Ext
861063138303
Email
zhaowww263@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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