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Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma

This study has been terminated.
(The research is permanently closed to enrollment.)
Sponsor:
Collaborator:
Unicorn Pacific Corporation
Information provided by (Responsible Party):
Jagannath, Sundar, M.D.
ClinicalTrials.gov Identifier:
NCT01096810
First received: February 22, 2010
Last updated: June 14, 2016
Last verified: June 2016
Results First Received: March 24, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: TBL 12

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TBL 12 TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression

Participant Flow:   Overall Study
    TBL 12  
STARTED     20  
COMPLETED     20  
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.
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Reporting Groups
  Description
TBL 12 TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression

Baseline Measures
    TBL 12  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Median (Full Range)
  58  
  (22 to 75)  
Gender  
[units: participants]
 
Female     9  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     20  
Bone Marrow Plasmacytosis  
[units: percentage of participants]
  38  



  Outcome Measures
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1.  Primary:   Time to Progression   [ Time Frame: From date of treatment until the date of first documented progression ]

2.  Primary:   Response Rate   [ Time Frame: from date of start of treatment until the date of best documented response up to date of progression ]

3.  Secondary:   Antitumor Effect   [ Time Frame: Antitumor effect ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sundar Jagannath
Organization: Mount Sinai
phone: 2122417873
e-mail: sundar.jagannath@mountsinai.org



Responsible Party: Jagannath, Sundar, M.D.
ClinicalTrials.gov Identifier: NCT01096810     History of Changes
Other Study ID Numbers: TBL 12
Study First Received: February 22, 2010
Results First Received: March 24, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration