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

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ClinicalTrials.gov Identifier: NCT02572596
Recruitment Status : Unknown
Verified February 2017 by Wang Guorong, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : October 9, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Wang Guorong, Beijing Chao Yang Hospital

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 Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2013
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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 Name: 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 Name: 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 Name: 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 Name: granulocyte colony-stimulatingG




Primary Outcome Measures :
  1. Number of CD34+ stem/progenitor cells that are mobilized [ Time Frame: two weeks ]

Secondary Outcome Measures :
  1. rate of mobilization success [ Time Frame: two weeks ]
  2. rate of mobilization optimal [ Time Frame: two weeks ]

Other Outcome Measures:
  1. occurrence rate of febrile neutropenia [ Time Frame: three weeks ]
  2. platelet transfusion amount [ Time Frame: three weeks ]
  3. time of neutrophil engraftment [ Time Frame: four weeks ]
  4. time of platelet engraftment [ Time Frame: eight weeks ]


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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572596


Contacts
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Contact: Guorong Wang, doctor +86 10 85231572 blunlake@163.com

Locations
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China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Guorong Wang, doctor    +861085231572    blunlake@163.com   
Contact: Wenming Chen, doctor    +861085231581    wenming_chen@yahoo.com   
Sponsors and Collaborators
Wang Guorong
Investigators
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Principal Investigator: Wenming Chen, doctor Beijing Chao Yang Hospital,CCMU
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Responsible Party: Wang Guorong, Clinical Professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02572596    
Other Study ID Numbers: MM-TPO-01
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Wang Guorong, Beijing Chao Yang Hospital:
Hematopoietic Stem Cell Mobilization
Thrombopoietin
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists