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
measurements. 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 for
one year 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression to symptomatic disease (CRAB symptoms)
To determine the response rate and time to progression of asymptomatic multiple myeloma patients receiving TBL 12.
Sundar Jagannath, MD
Mount Sinai School of Medicine
United States: Food and Drug Administration
|Mount Sinai Medical Center||New York, New York 10029|