Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Tabalumab; Bortezomib IV; Bortezomib SC; Dexamethasone
Intervention description: Administered IV; Administered IV; Administered SC; Administered orally
Intervention MeSH terms: Dexamethasone; Bortezomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effect on the body of Tabalumab
      (LY2127399) in combination with bortezomib and dexamethasone in Japanese participants with
      relapsed or refractory multiple myeloma (MM).
    

Eligibility criteria:

        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:

               1. positive for hepatitis B surface antigen (HBsAg+). OR

               2. positive for anti-hepatitis B core antibody and positive for hepatitis B
                  deoxyribonucleic acid (HBV DNA).

                  OR

               3. 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.