A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Placebo; Dexamethasone; Bortezomib; Tabalumab
Intervention description: Administered IV; Administered orally; Administered SQ; Administered IV
Intervention MeSH terms: Dexamethasone; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate an investigational drug called tabalumab in
      participants with Multiple Myeloma (MM) who have tried at least one other therapy in the
      past. Tabalumab will be given in combination with standard doses of two other drugs that are
      often used to treat MM. Study doctors will collect information about the effectiveness and
      side effects of this therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have symptomatic and/or progressive MM that was previously treated with at least 1 and
             no more than 3 prior lines of therapy

          -  Have measurable disease

          -  Have given written informed consent prior to any study-specific procedures

          -  Have adequate organ function

          -  Treatment with prior autologous transplant is permitted

        Exclusion Criteria:

          -  Are enrolled in or discontinued from a clinical trial of any drug or device within 21
             days prior to the first dose of assigned study treatment

          -  Have had less than a minimal response or have had progressive disease within 60 days
             of most recent therapy with a proteasome inhibitor

          -  Plan to proceed to autologous transplant for consolidation after participation in this
             trial

          -  Have an active infection or ongoing treatment for systemic infection ("ongoing
             treatment" does not include prophylactic anti-infectives),, chest x-ray suggestive of
             tuberculosis, or history/risk of chronic/latent infection that may reactivate in the
             presence of study therapy

          -  Have any of the following:

               -  positive test results for human immunodeficiency virus (HIV)

               -  positive test for hepatitis B, 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)

               -  positive test results for hepatitis C virus (HCV), defined as positive for
                  hepatitis C antibody (HepCAb) AND confirmed positive via the hepatitis C
                  recombinant immunoblot assay

          -  Have had significant allergy to human/humanized monoclonal antibodies that, in the
             opinion of the investigator, poses an unacceptable risk to the participants

          -  Have known hypersensitivity or contraindication to any of the study therapies or
             excipients

          -  Prior allogeneic hematopoietic stem cell transplant

          -  Prior therapy with experimental agents targeting B-cell activating factor (BAFF),
             including LY2127399

          -  Have corrected QT (QTc) interval >500 millisecond (msec) on baseline 12-lead
             electrocardiogram (ECG)

          -  Have Waldenstrom's macroglobulinemia

          -  History of malignancy with adequately treated basal cell or squamous cell skin cancer,
             in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible
             regardless of the time of diagnosis/treatment