Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients

Wang Guorong

Status: Unknown

Conditions: Multiple Myeloma

Treatments: Drug: CTX; Drug: -CSF; Drug: rhTPO

Study type: Interventional

Funder types: Other

Identifiers

NCT02572596

MM-TPO-01

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 200 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

rhTPO treatment group

Experimental group

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.

Treatment:

Drug: rhTPO

Drug: -CSF

Drug: CTX

non- rhTPO treatment group

Active Comparator group

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.

Treatment:

Drug: -CSF

Drug: CTX