Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma

The study has 3 cohorts. Cohort 2 and cohort 2-SC will be conducted in parallel with some data presented combined.

Cohort 1 - Participants will receive 100 mg Tabalumab (LY2127399) intravenously (IV), 1.3 milligram per square meter (mg/m^2) bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2 - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m^2 bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2-SC - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m^2 bortezomib subcutaneously (SC), and 20 mg dexamethasone orally.

Cohort 2-SC was added per protocol amendment in February 2013.

Inclusion criteria

• Have relapsed or refractory MM treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there was previously at least a minimal response (MR).
• Have measurable disease as defined by one or more of the following:

• serum M-protein concentration ≥ 1 g/dL (10 g/L)
• urine monoclonal light chain concentration ≥ 200 mg/24 hours as determined by urine protein electrophoresis
• involved serum free light chain (SFLC) concentration ≥ 10 mg/dL (100 mg/L) and an abnormal SFLC ratio
• Have adequate organ function including:

• Absolute neutrophil count (ANC) ≥ 1000/microliter
• Platelet (PLT) count ≥ 75,000/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, participant is eligible)
• Aspartate transaminase (AST) and alanine aminotransferase (ALT) are ≤ 3 x ULN
• Serum creatinine ≤ 3.0 mg/dL.
• Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of ≤ 2.
• Have discontinued all previous therapies for cancer, including chemotherapy, surgery, and radiotherapy for at least 2 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy.
• Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
• Females with childbearing potential: Must have had a negative urine or serum pregnancy test <7 days before the first dose of study drug.
• Have an estimated life expectancy of ≥16 weeks, in the opinion of the investigator.

Exclusion criteria

• Have received treatment within 30 days of the initial dose of study drug with an experimental agent for non-cancer indications 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 an uncontrolled infection.
• Females who are pregnant or breastfeeding.
• Have known positive test results for human immunodeficiency virus (HIV), hepatitis B*, or hepatitis C antibodies (HCAb).

• Have evidence of or test positive for hepatitis B. A positive test for hepatitis B is defined as:
• positive for hepatitis B surface antigen (HBsAg+). OR
• positive for anti-hepatitis B core antibody and positive for hepatitis B deoxyribonucleic acid (HBV DNA).

OR

• positive for anti-hepatitis B surface antibody (HBsAb+) and positive for hepatitis B deoxyribonucleic acid (HBV DNA).
• Have ≥ Grade 2 peripheral neuropathy or any grade with pain as assessed using the Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v 4.03).
• Have previously received an allogenic hematopoietic stem cell transplant.
• Have previously received treatment with an experimental agent that targets B-cell activating factor (BAFF).
• Have a corrected QT (QTc) interval >470 msec on their baseline electrocardiogram (ECG).
• Have interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on chest X-ray or computed tomography (CT) scan.
• Have had another active malignancy within the past 5 years.