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

• Sponsor: Jagannath, Sundar, M.D. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01096810
• Collaborator: Unicorn Pacific Corporation (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 65.9
• Patients Per Site Per Month: 0.3

Study Details

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
• 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: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 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 Names: Sea Cucumber

Outcome Measures

Primary Outcome Measures

1. Time to Progression [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 [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 [Antitumor effect]

   To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jagannath, Sundar, M.D.
• ClinicalTrials.gov Identifier: NCT01096810
• Other Study ID Numbers: TBL 12
• First Posted: Mar 31, 2010
• Last Update Posted: Jul 22, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Arm/Group Title	TBL 12
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

Baseline Characteristics

Arm/Group Title	TBL 12
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 Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Region of Enrollment (participants) [Number]
United States	20 100%
Bone Marrow Plasmacytosis (percentage of participants) [Number]
Number [percentage of participants]	38 190%

Outcome Measures

1. Primary Outcome

Title	Time to Progression
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TBL 12
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
Measure Participants	20
Median (Full Range) [cycles]	15

2. Primary Outcome

Title	Response Rate
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TBL 12
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
Measure Participants	20
Number [percentage of participants]	5 25%

3. Secondary Outcome

Title	Antitumor Effect
Description	To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis
Time Frame	Antitumor effect

Outcome Measure Data

Analysis Population Description

immunophenotyping was not performed in this study

Arm/Group Title	TBL 12
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
Measure Participants	0

Adverse Events

Arm/Group Title	TBL 12
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TBL 12
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
General disorders
Pneumococcal Pneumonia	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	TBL 12
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
General disorders
Nausea	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.