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

This study is ongoing, but not recruiting participants.
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: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

Purpose:

The purpose of this study is to see if the food supplement, 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

Condition Intervention Phase
Multiple Myeloma
 Drug: TBL 12
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Jagannath, Sundar, M.D.:

Primary Outcome Measures:
  • Time to progression to symptomatic disease (CRAB symptoms) [ Designated as safety issue: No ]
    To determine the response rate and time to progression of asymptomatic multiple myeloma patients receiving TBL 12.


Secondary Outcome Measures:
  • Antitumor effect [ Designated as safety issue: No ]
    To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis


Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096810

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Jagannath, Sundar, M.D.
Unicorn Pacific Corporation
Investigators
Principal Investigator: Sundar Jagannath, MD Mount Sinai School of Medicine
  More Information

No publications provided

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
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jagannath, Sundar, M.D.:
Asymptomatic

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013