Myeloma Clinical Trial
Official title:
A Phase II Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
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.
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. The
investigators 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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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