Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments rhtpo, ctx, -csf
Sponsor Wang Guorong
Start date January 2013
End date December 2016
Trial size 200 participants
Trial identifier NCT02572596, MM-TPO-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
rhtpo recombinant human thrombopoietin
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 Cyclophosphamide
CTX 2.5/m2 for 2 days.
-csf 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.
(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.
ctx Cyclophosphamide
CTX 2.5/m2 for 2 days.
-csf 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.

Primary Outcomes

Measure
Number of CD34+ stem/progenitor cells that are mobilized
time frame: two weeks

Secondary Outcomes

Measure
rate of mobilization success
time frame: two weeks
rate of mobilization optimal
time frame: two weeks

Eligibility Criteria

Male or female participants from 10 years up to 70 years old.

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.

Additional Information

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
Principal investigator Wenming Chen, doctor
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 .
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Beijing Chao Yang Hospital.