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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02572596
• Other study ID #: MM-TPO-01
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2015
• Last updated: February 8, 2017
• Start date: January 1, 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2017
• Source: Beijing Chao Yang Hospital
• Contact: Guorong Wang, doctor
• Phone: +86 10 85231572
• Email: blunlake[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Wang Guorong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	occurrence rate of febrile neutropenia		three weeks
Other	platelet transfusion amount		three weeks
Other	time of neutrophil engraftment		four weeks
Other	time of platelet engraftment		eight weeks
Primary	Number of CD34+ stem/progenitor cells that are mobilized		two weeks
Secondary	rate of mobilization success		two weeks
Secondary	rate of mobilization optimal		two weeks