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

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ClinicalTrials.gov Identifier: NCT01096810
Recruitment Status : Terminated (The research is permanently closed to enrollment.)
First Posted : March 31, 2010
Results First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborator:
Unicorn Pacific Corporation
Information provided by (Responsible Party):
Jagannath, Sundar, M.D.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: TBL 12
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TBL 12
Hide Arm/Group Description TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title TBL 12
Hide Arm/Group Description TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
58
(22 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Bone Marrow Plasmacytosis  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 20 participants
38
1.Primary Outcome
Title Time to Progression
Hide Description

To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles).

Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: >25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), >25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), >25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause).

Time Frame From date of treatment until the date of first documented progression
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TBL 12
Hide Arm/Group Description:
TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: cycles
15
(2 to 54)
2.Primary Outcome
Title Response Rate
Hide Description

The response rate - percentage of participants with overall response.

Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least >50% reduction in SPEP, at least >90% reduction or <200 mg in UPEP, at least >50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate.

Time Frame from date of start of treatment until the date of best documented response up to date of progression
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TBL 12
Hide Arm/Group Description:
TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
5
3.Secondary Outcome
Title Antitumor Effect
Hide Description To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis
Time Frame Antitumor effect
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
immunophenotyping was not performed in this study
Arm/Group Title TBL 12
Hide Arm/Group Description:
TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TBL 12
Hide Arm/Group Description TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
All-Cause Mortality
TBL 12
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TBL 12
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
General disorders   
Pneumococcal Pneumonia [1]  1/20 (5.00%)  1
[1]
Pneumococcal pneumonia requiring admission, which was felt to be unrelated to study treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TBL 12
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
General disorders   
Nausea  1/20 (5.00%)  1
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
Responsible Party: Jagannath, Sundar, M.D.
ClinicalTrials.gov Identifier: NCT01096810     History of Changes
Other Study ID Numbers: TBL 12
First Submitted: February 22, 2010
First Posted: March 31, 2010
Results First Submitted: March 24, 2016
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016