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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.

Tracking Information
First Submitted Date  ICMJE February 22, 2010
First Posted Date  ICMJE March 31, 2010
Results First Submitted Date  ICMJE March 24, 2016
Results First Posted Date  ICMJE July 22, 2016
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Time to Progression [ Time Frame: From date of treatment until the date of first documented progression ]
    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).
  • Response Rate [ Time Frame: from date of start of treatment until the date of best documented response up to date of progression ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Time to progression to symptomatic disease (CRAB symptoms)
To determine the response rate and time to progression of asymptomatic multiple myeloma patients receiving TBL 12.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Antitumor Effect [ Time Frame: Antitumor effect ]
To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Antitumor Effect
To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma
Official Title  ICMJE A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
Brief Summary

Purpose:

The purpose of this study is to see if TBL 12, which is a blend of Sea Cucumber, Sea Sponge, Shark Fin, and Sea Urchin (animals that live in the Pacific Ocean) as well as Sargassum (a plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple myeloma and to see what the side effects are.

Eligibility:

Several criteria must be met to be eligible for this study, including but not limited to the following:

  • a diagnosis of asymptomatic multiple myeloma
  • adequate cardiac, liver and kidney function
  • age 18 and older
Detailed Description Multiple myeloma is a cancer that evolves from a state known as Monoclonal Gammopathy of Undetermined Significance (MGUS), defined by parameters of M spike and bone marrow. After evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of hypercalcemia, renal insufficiency, anemia or bone lesions. In asymptomatic myeloma (ASxM), there is no standard therapy. Thalidomide has been tried in patients with ASxM but with significant toxicity. The patients with ASxM are evaluable in terms of paraprotein measurements. TBL12 sea cucumber extract has been shown to have a number of antitumor properties preclinically, including antiangiogenesis and direct tumor cytotoxicity. TBL12 has been used by a number of patients as a food supplement without any toxicity detected. We thus propose to determine the clinical activity of this agent in patients with ASxM. Patients will be given TBL12 at the dose of 2 units of 20 mL each twice per day daily for one year and the effects on the paraprotein noted. Clinical effects seen will be correlated with any in vitro changes in angiogenesis in patient bone marrow samples. The results of this trial may form the basis for the use of this nontoxic agent in patients with the prodrome of or with other early cancers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: TBL 12
TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.
Other Name: Sea Cucumber
Study Arms  ICMJE Experimental: 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
Intervention: Drug: TBL 12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 30, 2010)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of multiple myeloma
  • Measurable disease
  • For non-secretors, measurable protein by Freelite or plasmacytoma
  • Asymptomatic disease

Exclusion Criteria:

  • POEMS syndrome
  • Plasma cell leukemia
  • Receiving steroids greater than the equivalent of 10 mg prednisone
  • Infection not controlled by antibiotics
  • HIV infection
  • Known active hepatitis B or C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096810
Other Study ID Numbers  ICMJE TBL 12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jagannath, Sundar, M.D.
Study Sponsor  ICMJE Jagannath, Sundar, M.D.
Collaborators  ICMJE Unicorn Pacific Corporation
Investigators  ICMJE
Principal Investigator: Sundar Jagannath, MD Icahn School of Medicine at Mount Sinai
PRS Account Jagannath, Sundar, M.D.
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP