Study Stopped
lack of efficacy in Multiple myeloma
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma
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
1 other identifier
interventional
23
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Oct 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedApril 25, 2024
April 1, 2024
2.6 years
October 17, 2008
April 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum M protein levels
one month
Secondary Outcomes (1)
Time to progression or death
6 months
Study Arms (1)
BIW-8962, monoclonal antibody
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Ongoing infection
- Cardiac disease
- Uncontrolled hypertension
- Active liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin Co., Ltd.lead
- Kyowa Hakko Kirin Pharma, Inc.collaborator
Study Sites (5)
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201-2014, United States
Duke Medical Center
Durham, North Carolina, 27705, United States
Taussig Cancer Center- Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Baz RC, Zonder JA, Gasparetto C, Reu FJ, Strout V. Phase I Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Patients with Previously Treated Multiple Myeloma. Oncol Ther. 2016;4(2):287-301. doi: 10.1007/s40487-016-0034-y. Epub 2016 Nov 2.
PMID: 28261656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Zonder, MD
Karmanos Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 20, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2011
Study Completion
October 1, 2011
Last Updated
April 25, 2024
Record last verified: 2024-04