Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
February 8, 2017 updated by: Wang Guorong
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chaoyang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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:
CTX 2.5/m2 for 2 days.
Other Names:
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:
|
|
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.
|
CTX 2.5/m2 for 2 days.
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of CD34+ stem/progenitor cells that are mobilized
Time Frame: two weeks
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of mobilization success
Time Frame: two weeks
|
two weeks
|
|
rate of mobilization optimal
Time Frame: two weeks
|
two weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
occurrence rate of febrile neutropenia
Time Frame: three weeks
|
three weeks
|
|
platelet transfusion amount
Time Frame: three weeks
|
three weeks
|
|
time of neutrophil engraftment
Time Frame: four weeks
|
four weeks
|
|
time of platelet engraftment
Time Frame: eight weeks
|
eight weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wenming Chen, doctor, Beijing Chao Yang Hospital,CCMU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ANTICIPATED)
December 31, 2017
Study Completion (ANTICIPATED)
December 31, 2018
Study Registration Dates
First Submitted
September 17, 2015
First Submitted That Met QC Criteria
October 8, 2015
First Posted (ESTIMATE)
October 9, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- MM-TPO-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.