Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The research is permanently closed to enrollment.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TBL 12 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TBL 12
- description
- TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
- interventionNames
- Drug: TBL 12
Primary outcomes (2)
- measure
- Time to Progression
- timeFrame
- From date of treatment until the date of first documented 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available