Back to resultsComparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rhTPO
CTX
-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Hematopoietic Stem Cell Mobilization, Thrombopoietin
Eligibility Criteria
Inclusion Criteria:
- Diagnosed MM fulfill the International Myeloma Working Group (IMWG) criteria for MM diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
- Age at least 18 ys , no more than 70 ys old
- No active infectious disease; no severe organ failure (except renal failure secondary to MM)
- All screening procedures and evaluations should be completed
- All patients should provide written informed consent.
Exclusion Criteria:
- severe impaired liver function; HIV positive or had active hepatitis A, B or C infection; hepatitis B virus-DNA more than 10^4/L;aspartate aminotransferase ( AST) and alanine aminotransferase (ALT) more than 2.5 upper limit of normal (ULN)
- any disease that could put patients at high risk, including but not limited to unstable cardiac disease, defined as myocardial infarction in the previous 6 months, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled atrial fibrillation or hypertension
- severe prior thrombosis-event
- history of other malignancy, unless cured for more than 3 years
- pregnancy, lactation or disagreement to take contraceptive measures
- severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
- epilepsia, dementia or any mental disease requiring treatment.
Sites / Locations
- Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
rhTPO treatment group
non- rhTPO treatment group
Arm Description
Subject will receive chemotherapy with intermediate-dose CTX 2.5/m2 for 2 days. 10 ug/kg/d of G-CSFwas administered from the WBC was lower than 1×10^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed. rhTPO was administered 15 000 U/d once daily by subcutaneous injection from day 5-7 after chemotherapy and until the stem cell collection was completed.
Subject will receive chemotherapy with intermediate-dose CTX 2.5/m2 for 2 days. 10 ug/kg/d of G-CSF was administered from the WBC was lower than 1×10^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed.
Outcomes
Primary Outcome Measures
Number of CD34+ stem/progenitor cells that are mobilized
Secondary Outcome Measures
rate of mobilization success
rate of mobilization optimal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02572596
Brief Title
Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
Official Title
A Prospective Control Study of Comparing Intermediate-dose Cyclophosphamide(ID-CTX) and G-CSF Plus or Not Recombinant Human Thrombopoietin (rhTPO) for PBSC Mobilization in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2013 (undefined)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wang Guorong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparing intermediate-dose CTX (ID-CTX)and G-CSF with rhTPO or without for peripheral blood stem cell mobilization in patients with multiple myeloma, try to find out whether rhTPO combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell mobilization.
Detailed Description
The purpose of this study is to try to find out whether rhTPO combined to ID-CTX + G-CSF could improve the results of peripheral blood stem cell mobilization. Comparing ID-CTX and G-CSF plus rhTPO or not for peripheral blood stem cell mobilization in patients with multiple myeloma. rhTPO15000U/d were given from day 5~7 after chemotherapy until the stem cell collection .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Hematopoietic Stem Cell Mobilization, Thrombopoietin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhTPO treatment group
Arm Type
Experimental
Arm Description
Subject will receive chemotherapy with intermediate-dose CTX 2.5/m2 for 2 days. 10 ug/kg/d of G-CSFwas administered from the WBC was lower than 1×10^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed. rhTPO was administered 15 000 U/d once daily by subcutaneous injection from day 5-7 after chemotherapy and until the stem cell collection was completed.
Arm Title
non- rhTPO treatment group
Arm Type
Active Comparator
Arm Description
Subject will receive chemotherapy with intermediate-dose CTX 2.5/m2 for 2 days. 10 ug/kg/d of G-CSF was administered from the WBC was lower than 1×10^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed.
Intervention Type
Drug
Intervention Name(s)
rhTPO
Other Intervention Name(s)
recombinant human thrombopoietin, Recombinant Human TPO
Intervention Description
rhTPO was administered 15 000 U/d once daily by subcutaneous injection from day 5-7 after chemotherapy and until the stem cell collection was completed.
Intervention Type
Drug
Intervention Name(s)
CTX
Other Intervention Name(s)
Cyclophosphamide
Intervention Description
CTX 2.5/m2 for 2 days.
Intervention Type
Drug
Intervention Name(s)
-CSF
Other Intervention Name(s)
granulocyte colony-stimulatingG
Intervention Description
10 ug/kg/d of G-CSFwas administered from the WBC was lower than 1×10^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed.
Primary Outcome Measure Information:
Title
Number of CD34+ stem/progenitor cells that are mobilized
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
rate of mobilization success
Time Frame
two weeks
Title
rate of mobilization optimal
Time Frame
two weeks
Other Pre-specified Outcome Measures:
Title
occurrence rate of febrile neutropenia
Time Frame
three weeks
Title
platelet transfusion amount
Time Frame
three weeks
Title
time of neutrophil engraftment
Time Frame
four weeks
Title
time of platelet engraftment
Time Frame
eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed MM fulfill the International Myeloma Working Group (IMWG) criteria for MM diagnosis
Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
Age at least 18 ys , no more than 70 ys old
No active infectious disease; no severe organ failure (except renal failure secondary to MM)
All screening procedures and evaluations should be completed
All patients should provide written informed consent.
Exclusion Criteria:
severe impaired liver function; HIV positive or had active hepatitis A, B or C infection; hepatitis B virus-DNA more than 10^4/L;aspartate aminotransferase ( AST) and alanine aminotransferase (ALT) more than 2.5 upper limit of normal (ULN)
any disease that could put patients at high risk, including but not limited to unstable cardiac disease, defined as myocardial infarction in the previous 6 months, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled atrial fibrillation or hypertension
severe prior thrombosis-event
history of other malignancy, unless cured for more than 3 years
pregnancy, lactation or disagreement to take contraceptive measures
severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
epilepsia, dementia or any mental disease requiring treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guorong Wang, doctor
Phone
+86 10 85231572
Email
blunlake@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenming Chen, doctor
Organizational Affiliation
Beijing Chao Yang Hospital,CCMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guorong Wang, doctor
Phone
+861085231572
Email
blunlake@163.com
First Name & Middle Initial & Last Name & Degree
Wenming Chen, doctor
Phone
+861085231581
Email
wenming_chen@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
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