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A Phase II Trial of TBL-12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of TBL-12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Multiple myeloma is a cancer that evolves from a state known as Monoclonal Gammopathy of
Undetermined Significance (MGUS), defined by parameters of M spike and bone marrow. After
evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of
hypercalcemia, renal insufficiency, anemia or bone lesions. In asymptomatic myeloma (ASxM),
there is no standard therapy. Thalidomide has been tried in patients with ASxM but with
significant toxicity. The patients with ASxM are evaluable in terms of paraprotein

TBL12 sea cucumber extract has been shown to have a number of antitumor properties
preclinically, including antiangiogenesis and direct tumor cytotoxicity. TBL12 has been
used by a number of patients as a food supplement without any toxicity detected. We thus
propose to determine the clinical activity of this agent in patients with ASxM. Patients
will be given TBL12 at the dose of 2 units of 20 mL each twice per day daily until disease
progression and the effects on the paraprotein noted. Clinical effects seen will be
correlated with any in vitro changes in angiogenesis in patient bone marrow samples. The
results of this trial may form the basis for the use of this nontoxic agent in patients with
the prodrome of or with other early cancers.

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

Minor Criteria

- Bone marrow plasmacytosis (10 to 30% plasma cells)

- Monoclonal immunoglobulin present but of lesser magnitude than given under major

- 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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients who haven't progressed at 1 year of treatment

Outcome Description:

Assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Amitabha Mazumder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU School of Medicine, Clinical Cancer Center


United States: Food and Drug Administration

Study ID:

NYU# 10-02181



Start Date:

February 2011

Completion Date:

June 2014

Related Keywords:

  • Myeloma
  • multiple myeloma
  • myeloma
  • asymptomatic myeloma
  • smoldering myeloma
  • Asymptomatic (smoldering) myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



New York University School of Medicine, Clinical Cancer Center New York, New York  10016