A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01458288
First received: October 13, 2011
Last updated: December 25, 2014
Last verified: December 2014
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Non-hodgkin's Lymphoma
Hodgkin's Disease
Intervention: Drug: TG-0054

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Duration of the Study:

This study will consist of a 14-day screening period, a 2- to 11-day treatment period, and a 7-day follow-up period.

Number of Patients:

Approximately 12 treatment evaluable patients will be enrolled in this study.

Study Location: Single site in US.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)

TG-0054 (3.14 mg/kg)

TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)


Participant Flow:   Overall Study
    TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)

TG-0054 (3.14 mg/kg)

TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)


Baseline Measures
    TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)  
Number of Participants  
[units: participants]
  12  
Age, Customized  
[units: participants]
 
18 to 75 years old     12  
Gender  
[units: participants]
 
Female     6  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg   [ Time Frame: 1 week ]

2.  Secondary:   the Average Number of Leukapheresis Sessions   [ Time Frame: 1 week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   the Safety of TG-0054 in Patients With MM, NHL or HD   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   the Pharmacodynamics (PD) of TG-0054   [ Time Frame: pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chen-En Tsai, M.D., Ph.D.
Organization: TaiGen Biotechnology Co., Ltd.
phone: +886-2-8177-7072 ext 1211
e-mail: cetsai@taigenbiotech.com


No publications provided


Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01458288     History of Changes
Other Study ID Numbers: TG-0054-03
Study First Received: October 13, 2011
Results First Received: December 16, 2014
Last Updated: December 25, 2014
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health