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

NCT01302366 | Terminated Phase 2 Results DMC

• 1 other identifier: NYU# 10-02181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myeloma

Keywords

multiple myeloma; myeloma; asymptomatic myeloma; smoldering myeloma; Asymptomatic (smoldering) myeloma

Outcome Measures

Primary Outcomes (2)

• Duration of Response (All Treated Patients)

  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).

  up to 3 years

• Duration of Response (Excluding Patient Choice and Non-compliance)

  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).

  up to 3 years

Secondary Outcomes (1)

• Percentage of Patients Who Have Responded to TBL12

  2 months

Study Arms (1)

Sea cucumber extract

EXPERIMENTAL

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.

Drug: TBL12

Interventions

TBL12 DRUG

Sea cucumber extract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Unicorn Pacific Corporation: collaborator

Study Sites (1)

New York University School of Medicine, Clinical Cancer Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.

  PMID: 9753033 BACKGROUND

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma; Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia

Results Point of Contact

• Title: Amitabha Mazumder, MD
• Organization: Perlmutter Cancer Center at NYU Langone

amitabha.mazumder@nyumc.org

212-731-5757

Study Officials

• Amitabha Mazumder, MD

  NYU School of Medicine, Clinical Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 12, 2015
• Results First Posted: February 12, 2015

Record last verified: 2015-02

Locations

US (1)