A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Inclusion Criteria:

Diagnosis of multiple myeloma based on standard criteria as follows:

Major Criteria

Plasmacytomas on tissue biopsy
Bone marrow plasmacytosis (> 30% plasma cells)
Monoclonal immunoglobulin (Ig) spike on serum electrophoresis (IgG > 3.5 g/dL or IgA > 2.0 g/dL); kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis

Minor Criteria

Bone marrow plasmacytosis (10 to 30% plasma cells)
Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

Any of the following sets of criteria will confirm the diagnosis of Multiple Myeloma:

Any two of the major criteria
Major criterion 1 plus minor criterion b, c
Major criterion 3 plus minor criterion a or c

Minor criteria a, b and c

Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours.
Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
Has asymptomatic disease, i.e., does not have hypercalcemia, renal insufficiency, anemia or bone lesions.
Karnofsky performance status ≥ 80 (See Appendix B)
Is infertile (i.e. surgically sterile or 12 months post-menopausal) or is practicing an adequate form of contraception, as judged by the investigator (i.e., birth control pills, double barrier method, abstinence, etc.)
Age 18 years or older
Has given voluntary written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

Prior treatment for myeloma (symptomatic or asymptomatic).
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
Plasma cell leukemia
Patients with a history of thyroid problems.
Receiving steroids > the equivalent of 10 mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
Infection not controlled by antibiotics
Human Immunodeficiency Virus (HIV) infection. Patients should provide consent for HIV testing according to the institution's standard practice
Known active hepatitis B or C
New York Hospital Association (NYHA) Class III or IV heart failure or EKG evidence of acute ischemic disease
Second malignancy requiring treatment in last 3 years
Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Positive pregnancy test in women of childbearing potential