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

NCT01096810 | Terminated Phase 2 Results

• 1 other identifier: TBL 12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Keywords

Asymptomatic

Outcome Measures

Primary Outcomes (2)

• Time to 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).

  From date of treatment until the date of first documented progression

• Response Rate

  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.

  from date of start of treatment until the date of best documented response up to date of progression

Secondary Outcomes (1)

• Antitumor Effect

  Antitumor effect

Study Arms (1)

TBL 12

EXPERIMENTAL

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

Interventions

TBL 12 DRUG

TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.

Also known as: Sea Cucumber

TBL 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagannath, Sundar, M.D.: lead
• Unicorn Pacific Corporation: collaborator

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Sundar Jagannath
• Organization: Mount Sinai

sundar.jagannath@mountsinai.org

2122417873

Study Officials

• Sundar Jagannath, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: March 31, 2010
• Study Start: September 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 22, 2016
• Results First Posted: July 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)