Multiple MyelomaNCT02572596
Comparing Intermediate-dose CTX+ G-CSF Plus or Not rhTPO for PB CD34+ Cells Mobilization in MM Patients
A study testing rhTPO, CTX and -CSF in people with Multiple Myeloma, run by Wang Guorong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- rhTPO, CTX and -CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Guorong Wang, doctor, +861085231572, blunlake@163.com
Wenming Chen, doctor, +861085231581, wenming_chen@yahoo.com
About this study
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
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.
Read the 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 .
- Conditions
- Multiple Myeloma
- Being tested
- rhTPO, CTX, -CSF
- Keywords
- Hematopoietic Stem Cell Mobilization, Thrombopoietin
- Medical subject headings
- Multiple Myeloma, Jacobs syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
Also called recombinant human thrombopoietin, Recombinant Human TPO
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.
CTXDrug
Also called Cyclophosphamide
CTX 2.5/m2 for 2 days.
-CSFDrug
Also called granulocyte colony-stimulatingG
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.
| Study group | Role | What they receive |
|---|---|---|
| rhTPO treatment group | Experimental | 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. Receives: Drug: rhTPO; Drug: CTX; Drug: -CSF |
| non- rhTPO treatment group | Active comparator | 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. Receives: Drug: CTX; Drug: -CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CD34+ stem/progenitor cells that are mobilized
Measured: two weeks
Secondary outcomes (2)
rate of mobilization success
Measured: two weeks
rate of mobilization optimal
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Guorong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Guorong, Beijing Chao Yang Hospital
- Investigators
- Wenming Chen, doctor, Principal investigator, Beijing Chao Yang Hospital,CCMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572596
- Sponsor's protocol ID
- MM-TPO-01
- Status last verified
- Feb 2017
- First submitted
- 17 Sep 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02572596
- Acronym / sponsor ID
- MM-TPO-01
- Conditions
- Multiple Myeloma
- Keywords
- Hematopoietic Stem Cell Mobilization, Thrombopoietin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wang GuorongUniversity, hospital or other
- Study start
- 1 Jan 2013
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTPO treatment group | Experimental | Drug: rhTPO, Drug: CTX, Drug: -CSFSubject 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. |
| non- rhTPO treatment group | Active comparator | Drug: CTX, Drug: -CSFSubject 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. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPOAlso: recombinant human thrombopoietin, Recombinant Human TPOrhTPO 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 treatment group |
| CTXAlso: CyclophosphamideCTX 2.5/m2 for 2 days. | Drug | non- rhTPO treatment group, rhTPO treatment group |
| -CSFAlso: granulocyte colony-stimulatingG10 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. | Drug | non- rhTPO treatment group, rhTPO treatment group |
Primary outcome
Number of CD34+ stem/progenitor cells that are mobilized
Time frame: two weeks
2 secondary outcomes
rate of mobilization success
Time frame: two weeks
rate of mobilization optimal
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenming Chen, doctor principal investigator
Beijing Chao Yang Hospital,CCMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhTPO, CTX and -CSF in people with Multiple Myeloma, run by Wang Guorong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guorong Wang, doctor (+86 10 85231572, blunlake@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CD34+ stem/progenitor cells that are mobilized (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.