Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
NCT ID: NCT02572596
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2013-01-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rhTPO treatment group
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.
rhTPO
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.
CTX
CTX 2.5/m2 for 2 days.
-CSF
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.
non- rhTPO treatment group
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.
CTX
CTX 2.5/m2 for 2 days.
-CSF
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.
Interventions
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rhTPO
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.
CTX
CTX 2.5/m2 for 2 days.
-CSF
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. 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
3. severe prior thrombosis-event
4. history of other malignancy, unless cured for more than 3 years
5. pregnancy, lactation or disagreement to take contraceptive measures
6. severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
7. epilepsia, dementia or any mental disease requiring treatment.
10 Years
70 Years
ALL
No
Sponsors
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Wang Guorong
OTHER
Responsible Party
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Wang Guorong
Clinical Professor
Principal Investigators
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Wenming Chen, doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital,CCMU
Locations
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Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MM-TPO-01
Identifier Type: -
Identifier Source: org_study_id
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