A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: TBL12
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; myeloma; asymptomatic myeloma; smoldering myeloma; Asymptomatic (smoldering) myeloma

Summary:

      This study proposes to determine the clinical activity of this agent in patients with
      asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active
      multiple myeloma, with very few-if any- side effects.
    

Eligibility criteria:

        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