Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00775502
Recruitment Status : Terminated (lack of efficacy in Multiple myeloma)
First Posted : October 20, 2008
Last Update Posted : June 15, 2016
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

Brief Summary:
This study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. This antibody is unique in its ability to promote the death of multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: BIW-8962 Phase 1

Detailed Description:

BIW-8962 is a monoclonal antibody which targets the GM-2 ganglioside which is expressed at high levels on the surface of multiple myeloma cells. This is a Phase 1/2 study design. The Phase 1 component will establish the active biologic dose (ABD) or the maximum tolerated dose (MTD) as well as the appropriate dosing frequency based on the pharmacokinetics of the antibody and approximately 45 subjects will be enrolled in this part of the study. The initial dosing frequency will be every two weeks and the doses to be tested will range from 0.03 mg/kg to 10 mg/kg. Once the recommended Phase 2 dose and frequency have been established in Phase 1, the efficacy of the drug will be investigated in approximately 35 subjects in Phase 2.

The study did not proceed beyond the Phase 1a portion.

On 30 Nov 2010, Kyowa Hakko Kirin Pharma, Inc. (KKP) notified Investigators of the decision to terminate BIW-8962-001 due to a lack of efficacy in Multiple Myeloma.

The Phase 1 Part B and the Phase 2 components of the study were not conducted. The study was terminated and summarized in an abbreviated clinical study report (submitted 26 June 2012; SN045). Kyowa Kirin Pharma has no current plans to pursue the use of BIW8962 in multiple myeloma.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Multiple Myeloma
Study Start Date : October 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BIW-8962, monoclonal antibody Drug: BIW-8962
Intravenous administration of liquid dosage form. Doses 0.03, 0.10, 0.30, 1.0, 3.0, and 10 mg/kg. Frequency is once every two weeks. Duration is 6 months
Other Name: anti GM2 monoclonal antibody

Primary Outcome Measures :
  1. Serum M protein levels [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Time to progression or death [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Relapsed or refractory myeloma
  • M-protein in serum and/or urine by IMWG criteria.
  • Bone marrow plasma cells or plasmacytoma
  • Related organ or tissue impairment (CRAB)
  • Subjects without detectable M protein are eligible if they have an abnormal serum free light chain ratio (FLC) or if they have at least 10% plasma cells in the bone marrow

Exclusion Criteria:

  • Ongoing infection
  • Cardiac disease
  • Uncontrolled hypertension
  • Active liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00775502

United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2014
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Taussig Cancer Center- Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Principal Investigator: Jeffrey Zonder, MD Karmanos Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Pharma, Inc. Identifier: NCT00775502     History of Changes
Other Study ID Numbers: BIW-8962-001
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: October 2012

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):
Multiple myeloma
GM-2 ganglioside
monoclonal antibody
Potelligent design
Treatment of subjects who have failed previous treatment

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs