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A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

This study has been terminated.
(due to lack of funding)
Sponsor:
Collaborator:
Unicorn Pacific Corporation
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01302366
First received: February 14, 2011
Last updated: February 11, 2015
Last verified: February 2015
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myeloma
Intervention: Drug: TBL12

  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
From March 2011 to October 2012, 20 patients were enrolled to the study from Perlmutter Cancer Center at NYU Lagone Medical Center.

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
Sea Cucumber Extract (TBL 12) TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.

Participant Flow:   Overall Study
    Sea Cucumber Extract (TBL 12)  
STARTED     20  
COMPLETED     15  
NOT COMPLETED     5  
patient choice or noncompliance                 5  



  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
Sea Cucumber Extract (TBL 12)

TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.

TBL-12


Baseline Measures
    Sea Cucumber Extract (TBL 12)  
Number of Participants  
[units: participants]
  20  
Age, Customized  
[units: participants]
 
35-44 years     1  
45-53 years     2  
54-63 years     9  
64-73 years     5  
74-83 years     3  
Gender  
[units: participants]
 
Female     8  
Male     12  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     15  
More than one race     0  
Unknown or Not Reported     3  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Duration of Response (All Treated Patients)   [ Time Frame: up to 3 years ]

2.  Primary:   Duration of Response (Excluding Patient Choice and Non-compliance)   [ Time Frame: up to 3 years ]

3.  Secondary:   Percentage of Patients Who Have Responded to TBL12   [ Time Frame: 2 months ]


  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: Amitabha Mazumder, MD
Organization: Perlmutter Cancer Center at NYU Langone
phone: 212-731-5757
e-mail: amitabha.mazumder@nyumc.org


Publications:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01302366     History of Changes
Other Study ID Numbers: NYU# 10-02181
Study First Received: February 14, 2011
Results First Received: January 26, 2015
Last Updated: February 11, 2015
Health Authority: United States: Food and Drug Administration