Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma
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.
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
|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|
- Time to Progression [ Time Frame: From date of treatment until the date of first documented progression ] [ Designated as safety issue: No ]
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).
- Response Rate [ Time Frame: from date of start of treatment until the date of best documented response up to date of progression ] [ Designated as safety issue: No ]
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.
- Antitumor Effect [ Time Frame: Antitumor effect ] [ Designated as safety issue: No ]To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis
|Study Start Date:||September 2008|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096810
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Principal Investigator:||Sundar Jagannath, MD||Icahn School of Medicine at Mount Sinai|