Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Jan 2013
Longer than P75 for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 9, 2017
February 1, 2017
5 years
September 17, 2015
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of CD34+ stem/progenitor cells that are mobilized
two weeks
Secondary Outcomes (2)
rate of mobilization success
two weeks
rate of mobilization optimal
two weeks
Other Outcomes (4)
occurrence rate of febrile neutropenia
three weeks
platelet transfusion amount
three weeks
time of neutrophil engraftment
four weeks
- +1 more other outcomes
Study Arms (2)
rhTPO treatment group
EXPERIMENTALSubject 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.
non- rhTPO treatment group
ACTIVE COMPARATORSubject 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wang Guoronglead
Study Sites (1)
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenming Chen, doctor
Beijing Chao Yang Hospital,CCMU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
September 17, 2015
First Posted
October 9, 2015
Study Start
January 1, 2013
Primary Completion
December 31, 2017
Study Completion
December 31, 2018
Last Updated
February 9, 2017
Record last verified: 2017-02