Overview

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

Status:
Terminated
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jagannath, Sundar, M.D.
Collaborator:
Unicorn Pacific Corporation
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