A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib
1 other identifier
interventional
48
1 country
6
Brief Summary
H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Mar 2008
Longer than P75 for phase_1 multiple-myeloma
6 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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 29, 2015
May 1, 2015
4.8 years
May 29, 2008
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose
2 years
Secondary Outcomes (3)
Safety and toxicity profile for LY2127399 in combination with bortezomib
2 years
Response rate, duration of response, and time to progression of LY2127399 in combination with bortezomib
2 years
Response rate, duration of response, and time to progression of LY2127399 as a single-agent
2 years
Study Arms (3)
Dose Escalation Phase(Part A):
EXPERIMENTAL1,10, 30, 100 or 300 mg of LY2127399 IV on day 1 of specific 21 day cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each 21 day cycle
Dose Confirmation Phase (Part B1):
EXPERIMENTALDose determined by PK/PD modeling, LY2127399 IV on day 2 of Cycle 1 and on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each cycle
Dose Confirmation Phase (Part B2):
EXPERIMENTALDose determined by PK/PD modeling, LY2127399 IV on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of specific cycles
Interventions
monoclonal antibody
Eligibility Criteria
You may qualify if:
- Have relapsed or refractory multiple myeloma treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there has been no relapse or progression within 3 months of the last dose of bortezomib, and bortezomib is considered by the treating physician to be a reasonable therapy for the patient.
- Have measurable disease defined by one or more of the following:
- Monoclonal protein in the serum of ≥1 g/dL (10 g/L).
- Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours.
- Involved Serum Free Light Chain (SFLC) level \> 10 mg/dL (100 mg/L) provided SFLC ratio is abnormal.
- Measurable plasmacytoma.
- Are ≥ 18 years of age.
- Have given written informed consent prior to any study-specific procedures
- Have adequate organ function including:
- Absolute neutrophil count (ANC) ≥ 1000/microliter
- Platelet (PLT) count ≥ 50,000/microliter
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (if total is elevated check direct and, if normal, patient is eligible)
- Aspartate transaminase (AST) ≤ 3 x ULN
- Creatinine ≤ 3.0 mg/dl.
- +7 more criteria
You may not qualify if:
- Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
- Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
- Have uncontrolled infection.
- Females who are pregnant or lactating.
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
- Have peripheral neuropathy of \> Grade 2, or of any grade with pain, as measured by CTCAE v3.0.
- Previously treated with LY2127399, or have had significant allergy to humanized monoclonal antibodies that, in the opinion of the investigator, poses an increased risk to the patient.
- Prior allogeneic hematopoietic stem cell transplant.
- Prior therapy with experimental agents targeting BAFF.
- Have QTc interval \> 450 msec on baseline 12-lead ECG.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Applied Molecular Evolutionlead
- Eli Lilly and Companycollaborator
Study Sites (6)
University of Alabama
Birmingham, Alabama, 35294-3300, United States
UCLA
Los Angeles, California, 90024, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susan Carpenter, PhD
Applied Molecular Evolution
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
May 29, 2008
First Posted
June 3, 2008
Study Start
March 1, 2008
Primary Completion
January 1, 2013
Study Completion
May 1, 2014
Last Updated
June 29, 2015
Record last verified: 2015-05