NCT01302366

A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

A Phase II Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Myeloma

Interventions

Type	Name	Description
DRUG	TBL12

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-02-24
• Last updated: 2015-02-12
• Results posted: 2015-02-12

Locations

1 site across 1 country: United States