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

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

Study Description

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

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: TBL 12	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of TBL 12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
• Study Start Date: September 2008
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
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	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

Outcome Measures

Primary Outcome Measures :

1. 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).

2. 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.

Secondary Outcome Measures :

1. Antitumor Effect [ Time Frame: Antitumor effect ]
   To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Jagannath, Sundar, M.D.
• ClinicalTrials.gov Identifier: NCT01096810
• Other Study ID Numbers: TBL 12
• First Posted: March 31, 2010
• Results First Posted: July 22, 2016
• Last Update Posted: July 22, 2016
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Asymptomatic

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma; 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; Precancerous Conditions; Hypergammaglobulinemia