A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
- 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
- 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.
- 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
- 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.