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