A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease
A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease
2 other identifiers
interventional
67
1 country
9
Brief Summary
The purpose of this study is to evaluate of the study of different CNTO 328 doses and schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma or Castleman's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2005
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 1, 2014
June 1, 2014
5.9 years
December 15, 2006
June 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Number of Patients with adverse events will be reported.
Up to 3 years after the last administration of study medication
Serum Concentration of CNTO 328
Serum Concentration of CNTO 328 will be reported.
Up to Day 71
Secondary Outcomes (7)
Pharmacodynamics of CNTO 328
Up to Day 71
Plasma antibodies to CNTO 328
Up to Week 24
Number of participants with Castleman's disease who achieved tumor response
Screening phase (4 weeks before administration of study medication), Day 36, and Day 57
Number of participants with multiple myeloma who achieved disease response
Screening phase (4 weeks before administration of study medication), Day 36, and Day 57
Number of participants with B-cell non-Hodgkin's lymphoma and multiple myeloma who achieved clinical benefit (CB)
Up to Day 71
- +2 more secondary outcomes
Study Arms (8)
Cohort 1 (CNTO 328)
EXPERIMENTALPatients will receive 4 administrations of 3 mg/kg CNTO 328 every 2 weeks till Day 43.
Cohort 2 (CNTO 328)
EXPERIMENTALPatients will receive 4 administrations of 6 mg/kg CNTO 328 every 2 weeks till Day 43.
Cohort 3 (CNTO 328)
EXPERIMENTALPatients will receive 3 administrations of 12 mg/kg CNTO 328 every 2 weeks till Day 43.
Cohort 4 (CNTO 328)
EXPERIMENTALPatients will receive 7 administrations of 6 mg/kg CNTO 328 every week till Day 43.
Cohort 5 (CNTO 328)
EXPERIMENTALPatients will receive 4 administrations of 12 mg/kg CNTO 328 every 2 weeks till Day 43.
Cohort 6 (CNTO 328)
EXPERIMENTALPatients will receive 3 administrations of 12 mg/kg CNTO 328 every 3 weeks till Day 43.
Cohort 7a (CNTO 328)
EXPERIMENTALPatients responding to CNTO 328 treatment will receive 9 mg/kg CNTO 328 every 3 weeks.
Cohort 7b (CNTO 328)
EXPERIMENTALPatients responding to CNTO 328 treatment will receive 12 mg/kg CNTO 328 every 3 weeks as extended administration.
Interventions
Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosed with B-cell non-Hodgkin's lymphoma, multiple myeloma, or Castleman's Disease which has progressed on or after standard therapy or for which there is no effective standard therapy, or which is not suitable for standard therapy
- Detectable serum C-Reactive Protein
- At least 4 weeks since prior systemic therapy, radiotherapy, or surgery
- Must meet protocol lab criteria (adequate bone marrow, liver and renal function) to be assessed at patient's first visit to the study center
You may not qualify if:
- Received any investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer
- Serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure
- Known human immunodeficiency virus seropositivity, acquired immunodeficiency syndome, hepatitis C or active hepatitis B infection. For Cohort 7, known human herpesvirus-8 seropositivity
- Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or an allogeneic peripheral blood stem cell transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (9)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Box 302, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Seattle, Washington, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
May 1, 2005
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 1, 2014
Record last verified: 2014-06