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

NCT ID: NCT02572596

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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 .

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

rhTPO

Intervention Type DRUG

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

Intervention Type DRUG

CTX 2.5/m2 for 2 days.

-CSF

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

CTX

Intervention Type DRUG

CTX 2.5/m2 for 2 days.

-CSF

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

CTX

CTX 2.5/m2 for 2 days.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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recombinant human thrombopoietin Recombinant Human TPO Cyclophosphamide granulocyte colony-stimulatingG

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wang Guorong

OTHER

Sponsor Role lead

Responsible Party

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Wang Guorong

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenming Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital,CCMU

Locations

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Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guorong Wang, doctor

Role: CONTACT

+86 10 85231572

Facility Contacts

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Guorong Wang, doctor

Role: primary

+861085231572

Wenming Chen, doctor

Role: backup

+861085231581

Other Identifiers

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MM-TPO-01

Identifier Type: -

Identifier Source: org_study_id

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