A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib

Inclusion Criteria

• •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.