Multiple Myeloma
Conditions
Keywords
Hematopoietic Stem Cell Mobilization, Thrombopoietin
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 .
Interventions
DRUGrhTPO
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.
DRUGCTX
CTX 2.5/m2 for 2 days.
DRUG-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.
Sponsors
Wang Guorong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
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
1. 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of CD34+ stem/progenitor cells that are mobilized | two weeks |
Secondary
| Measure | Time frame |
|---|---|
| rate of mobilization success | two weeks |
| rate of mobilization optimal | two weeks |
Other
| Measure | Time frame |
|---|---|
| occurrence rate of febrile neutropenia | three weeks |
| time of platelet engraftment | eight weeks |
| platelet transfusion amount | three weeks |
| time of neutrophil engraftment | four weeks |
Countries
China
Contacts
Primary ContactGuorong Wang, doctor
Outcome results
None listed