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. All subjects have completed all research-related interventions.)
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 8, 2014
Last verified: September 2014

February 22, 2010
September 8, 2014
September 2008
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01096810 on ClinicalTrials.gov Archive Site
Antitumor effect [ Designated as safety issue: No ]
To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis
Same as current
Not Provided
Not Provided
 
Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma
A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01096810
TBL 12
No
Jagannath, Sundar, M.D.
Jagannath, Sundar, M.D.
Unicorn Pacific Corporation
Principal Investigator: Sundar Jagannath, MD Mount Sinai School of Medicine
Jagannath, Sundar, M.D.
September 2014

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