Status:
COMPLETED
A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib
Lead Sponsor:
Applied Molecular Evolution
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 re...
Detailed Description
This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the saf...
Eligibility Criteria
Inclusion
- 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.
- Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale (refer to Attachment JDCF.5).
- Have discontinued all previous therapies for cancer, including chemotherapy and radiotherapy at least 2 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 4 months following the last dose of study drug.
- Females with child bearing potential must have had a negative urine or serum pregnancy test ≤ 3 days prior to the first dose of study drug.
- Have an estimated life expectancy of ≥ 16 weeks.
- Treatment with prior autologous transplant is permitted. If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered one line of treatment with the preceding chemotherapy.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00689507
Start Date
March 1 2008
End Date
May 1 2014
Last Update
June 29 2015
Active Locations (6)
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1
University of Alabama
Birmingham, Alabama, United States, 35294-3300
2
UCLA
Los Angeles, California, United States, 90024
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115