Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Trial Purpose and Description

Trial Purpose

People who have smoldering multiple myeloma do not have symptoms but are at risk for progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. People with active multiple myeloma generally require treatment. However, there are currently no approved therapies for smoldering multiple myeloma. The purpose of this study is to determine whether or not an investigational drug is effective and safe in treating people with high risk smoldering myeloma. The name of this investigational drug is elotuzumab. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Elotuzumab was observed to kill myeloma cells in laboratory studies.

Participation Guidelines

Eligibility Criteria

Inclusion Criteria:

·         Subjects with a confirmed diagnosis of smoldering multiple myeloma according to IMWG and that is considered high risk according to the following:

o    Serum M protein ≥ 3 gm/dL and bone marrow plasma cells (BMPC) ≥ 10% or

o    Serum M protein 1 - 3 g/dL and BMPC ≥ 10% and abnormal free light chain ratio of < 0.125 or > 8.0

Exclusion Criteria:

·         Active multiple myeloma

·         Monoclonal Gammopathy of Undetermined Significance (MGUS)

·         Active plasma cell leukemia

Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

Dates:

March 2012

Last Updated:

Study HIC#:

1110009170

Clinicaltrials.gov ID: Yale2110210