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

Sponsor

Wang Guorong (Other)

Overall Status

Unknown status

CT.gov ID

NCT02572596

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: rhTPO Drug: CTX Drug: -CSF	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rhTPO treatment group 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.	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. Other Names: recombinant human thrombopoietin Recombinant Human TPO Drug: CTX CTX 2.5/m2 for 2 days. Other Names: Cyclophosphamide 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. Other Names: granulocyte colony-stimulatingG
Active Comparator: non- rhTPO treatment group 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.	Drug: CTX CTX 2.5/m2 for 2 days. Other Names: Cyclophosphamide 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. Other Names: granulocyte colony-stimulatingG

Arm

Intervention/Treatment

Experimental: rhTPO treatment group

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.

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.

Other Names:

recombinant human thrombopoietin

Recombinant Human TPO

Drug: CTX

CTX 2.5/m2 for 2 days.

Other Names:

Cyclophosphamide

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.

Other Names:

granulocyte colony-stimulatingG

Active Comparator: non- rhTPO treatment group

Drug: CTX

CTX 2.5/m2 for 2 days.

Other Names:

Cyclophosphamide

Drug: -CSF

Other Names:

granulocyte colony-stimulatingG

Outcome Measures

Primary Outcome Measures

Number of CD34+ stem/progenitor cells that are mobilized [two weeks]

Secondary Outcome Measures

rate of mobilization success [two weeks]
rate of mobilization optimal [two weeks]

Other Outcome Measures

occurrence rate of febrile neutropenia [three weeks]
platelet transfusion amount [three weeks]
time of neutrophil engraftment [four weeks]
time of platelet engraftment [eight weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chaoyang Hospital	Beijing	Beijing	China	100020

Sponsors and Collaborators

Wang Guorong

Investigators

Principal Investigator: Wenming Chen, doctor, Beijing Chao Yang Hospital,CCMU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Guorong, Clinical Professor, Beijing Chao Yang Hospital

ClinicalTrials.gov Identifier:

NCT02572596

Other Study ID Numbers:

MM-TPO-01

First Posted:

Oct 9, 2015

Last Update Posted:

Feb 9, 2017

Last Verified:

Feb 1, 2017

Keywords provided by Wang Guorong, Clinical Professor, Beijing Chao Yang Hospital

Hematopoietic Stem Cell Mobilization

Thrombopoietin

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Cyclophosphamide

Study Results

No Results Posted as of Feb 9, 2017