Clinical trial NCT02572596: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Keywords: Hematopoietic Stem Cell Mobilization
Thrombopoietin
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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:

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.

Primary outcomes:
measure: Number of CD34+ stem/progenitor cells that are mobilized
timeFrame: two weeks
Secondary outcomes:
measure: rate of mobilization success
timeFrame: two weeks
measure: rate of mobilization optimal
timeFrame: two weeks
Other outcomes:
measure: occurrence rate of febrile neutropenia
timeFrame: three weeks
measure: platelet transfusion amount
timeFrame: three weeks
measure: time of neutrophil engraftment
timeFrame: four weeks
measure: time of platelet engraftment
timeFrame: eight weeks
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital,CCMU
name: Wenming Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: