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Multiple Myeloma

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Smoldering Multiple Myeloma

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Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Patients will get atezolizumab every 21 days for up to 1 year

Atezolizumab (1200mg via IV infusion)

Noffar Bar, MD

The purpose of this pilot study is to gain initial insights into the biologic and clinical effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially be relevant to its future development in Multiple Myeloma (MM) and other indications.

Pilot Study Of Anti-Programmed Death Ligand-1 (Anti-PD-L1, Atezolizumab) In Asymptomatic Myeloma

Presence or absence of SOX2 cells before and after anti-PDL1 therapy followed up to 1 year will be measured using antigen dependant stimulation.

Yale University

TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.

TBL12

Amitabha Mazumder, MD

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.

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

Response \[complete response (CR), partial response (PR), and stable disease (SD)\] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).

Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)

Unicorn Pacific Corporation

NYU Langone Health

All adverse events regardless of attribution are reported here.

Sea Cucumber Extract (TBL 12)

TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.

TBL-12

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study Of Anti-Programmed Death Ligand-1 (Anti-PD-L1, Atezolizumab) In Asymptomatic Myeloma	NCT02784483	Asymptomatic My...	Atezolizumab (1...	18 Years - 90 Years	Yale University
Pilot Study Of Anti-Programmed Death Ligand-1 (Anti-PD-L1, Atezolizumab) In Asymptomatic Myeloma	NCT02784483	Asymptomatic My...	Atezolizumab (1...	18 Years - 90 Years	Yale University
A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma	NCT01302366	Myeloma	TBL12	18 Years -	NYU Langone Health

Spots Global Cancer Trial Database for asymptomatic myeloma